Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

%FDFNCFS


℅ Mrs. Jean Lei
Engineer of Technical Regulation Department
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
P R CHINA

Re: K173369
Trade/Device Name: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: II
Product Code: IYN, IYO, ITX
Dated: October 27, 2017
Received: October 27, 2017

Dear Mrs. Lei:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. The general controls provisions of the Act include requirements for annual
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding
and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.
We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.02.03
Silver Spring, MD 20993
www.fda.gov
Page 2 – Mrs. Jean Lei K173369

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone
(1-800-638-2041 or 301-796-7100).

Sincerely,

'PS
Robert Ochs, Ph.D.
Director
Division of Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

,
Device Name
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System

Indications for Use (Describe)

Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for
use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-
vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (7/17) Page 1 of 10 PSC Publishing Services (301) 443-6740 EF

010-1
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: /
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitud Combined
(Track 1 B M PWD CWD Other (specify)
Doppler e Doppler (specify)
Only)
Ophthalmi Ophthalmic
     
c
Fetal N N N  N N N Note 1, 2, 3, 4, 5
Abdominal N N N  N N N Note 1, 2, 3, 4, 5, 7
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric N N N  N N N Note 1, 2, 4, 5
Small Organ (Specify**) N N N  N N N Note 1, 2, 4, 5, 6
Neonatal Cephalic N N N  N N N Note 1, 2, 4, 5
Fetal Adult Cephalic N N N  N N N Note 1, 2, 4, 5
Imaging &
Other Trans-rectal N N N  N N N Note 1, 2, 4, 5
Trans-vaginal N N N  N N N Note 1, 2, 4, 5
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional) N N N  N N N Note 1, 2, 4, 5, 6

Musculo-skeletal
(Superficial) N N N  N N N Note 1, 2, 4, 5, 6

Intravascular      
Cardiac Adult N N N  N N N Note 1, 2, 4, 5
Cardiac Pediatric N N N  N N N Note 1, 2, 4, 5
Cardiac Intravascular (Cardiac)      
Trans-esoph. (Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel N N N  N N N Note 1, 2, 4, 5
vessel Other (Specify***) N N N  N N N Note 1, 2, 4, 5
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page2of10

010-2
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: 35C50P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined
(Track 1 B M PWD CWD Other (specify)
Doppler Doppler (specify)
Only)
Ophthalmic Ophthalmic      
Fetal N N N  N N N Note 1, 2, 4, 5
Abdominal N N N  N N N Note 1, 2, 4, 5, 7
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric N N N  N N N Note 1, 2, 4, 5
Small Organ
     
(Specify**)
Neonatal Cephalic      
Fetal
Adult Cephalic      
Imaging &
Other Trans-rectal      
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional) N N N  N N N Note 1, 2, 4, 5

Musculo-skeletal
(Superficial)      

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph.(Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel N N N  N N N Note 1, 2, 4, 5
vessel Other (Specify***)      
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page3of10

010-3
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: 75L38P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined
(Track 1 B M PWD CWD Other (specify)
Doppler Doppler (specify)
Only)
Ophthalmic Ophthalmic      
Fetal      
Abdominal N N N  N N N Note 1, 2, 4, 5
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric N N N  N N N Note 1, 2, 4, 5
Small Organ (Specify**) N N N  N N N Note 1, 2, 4, 5, 6
Neonatal Cephalic N N N  N N N Note 1, 2, 4, 5
Fetal Adult Cephalic      
Imaging &
Other Trans-rectal      
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional) N N N  N N N Note 1, 2, 4, 5, 6

Musculo-skeletal
(Superficial) N N N  N N N Note 1, 2, 4, 5, 6

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph. (Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel N N N  N N N Note 1, 2, 4, 5
vessel Other (Specify***)      
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page4of10

010-4
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: 6CV1P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined Other
(Track 1 B M PWD CWD
Doppler Doppler (specify) (specify)
Only)
Ophthalmic Ophthalmic      
Fetal N N N  N N N Note 1, 2, 4, 5
Abdominal      
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric      
Small Organ (Specify**)      
Neonatal Cephalic      
Fetal Adult Cephalic      
Imaging &
Other Trans-rectal N N N  N N N Note 1, 2, 4, 5
Trans-vaginal N N N  N N N Note 1, 2, 4, 5
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional)      

Musculo-skeletal
(Superficial)      

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph. (Cardiac)      
Intra-cardiac      
Peripheral vessel      
Peripheral
vessel Other (Specify***) N N N  N N N Note 1, 2, 4, 5
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page5of10

010-5
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: 6C2P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined Other
(Track 1 B M PWD CWD
Doppler Doppler (specify) (specify)
Only)
Ophthalmic Ophthalmic      
Fetal      
Abdominal N N N  N N N Note 1, 2, 4, 5
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric N N N  N N N Note 1, 2, 4, 5
Small Organ
     
(Specify**)
Neonatal Cephalic      
Fetal
Adult Cephalic N N N  N N N Note 1, 2, 4, 5
Imaging &
Other Trans-rectal      
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional) N N N  N N N Note 1, 2, 4, 5

Musculo-skeletal
(Superficial) N N N  N N N Note 1, 2, 4, 5

Intravascular      
Cardiac Adult N N N  N N N Note 1, 2, 4, 5
Cardiac Pediatric N N N  N N N Note 1, 2, 4, 5
Cardiac Intravascular (Cardiac)      
Trans-esoph.(Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel N N N  N N N Note 1, 2, 4, 5
vessel Other (Specify***)      
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page6of10

010-6
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: D6-2P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined Other
(Track 1 B M PWD CWD
Doppler Doppler (specify) (specify)
Only)
Ophthalmic Ophthalmic      
Fetal N N N  N N N Note 1, 2, 3, 4
Abdominal N N N  N N N Note 1, 2, 3, 4
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric      
Small Organ
     
(Specify**)
Neonatal Cephalic      
Fetal
Adult Cephalic      
Imaging &
Other Trans-rectal      
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional)      

Musculo-skeletal
(Superficial)      

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph.(Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel      
vessel Other (Specify***)      
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page7of10

010-7
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: 7L4P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined Other
(Track 1 B M PWD CWD
Doppler Doppler (specify) (specify)
Only)
Ophthalmic Ophthalmic      
Fetal      
Abdominal N N N  N N N Note 1, 2, 4, 5
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric N N N  N N N Note 1, 2, 4, 5
Small Organ
N N N  N N N Note 1, 2, 4, 5
(Specify**)
Neonatal Cephalic N N N  N N N Note 1, 2, 4, 5
Fetal
Adult Cephalic      
Imaging &
Other Trans-rectal      
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional) N N N  N N N Note 1, 2, 4, 5

Musculo-skeletal
(Superficial) N N N  N N N Note 1, 2, 4, 5

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph.(Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel N N N  N N N Note 1, 2, 4, 5
vessel Other (Specify***)      
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page8of10

010-8
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: 3C5P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined Other
(Track 1 B M PWD CWD
Doppler Doppler (specify) (specify)
Only)
Ophthalmic Ophthalmic      
Fetal N N N  N N N Note 1, 2, 4, 5
Abdominal N N N  N N N Note 1, 2, 4, 5
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric N N N  N N N Note 1, 2, 4, 5
Small Organ
     
(Specify**)
Neonatal Cephalic      
Fetal
Adult Cephalic      
Imaging &
Other Trans-rectal      
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional) N N N  N N N Note 1, 2, 4, 5

Musculo-skeletal
(Superficial)      

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph.(Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel N N N  N N N Note 1, 2, 4, 5
vessel Other (Specify***)      
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page9of10

010-9
System: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Transducer: CB10-4P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General Specific (Track 1 & 3)
Color Amplitude Combined Other
(Track 1 B M PWD CWD
Doppler Doppler (specify) (specify)
Only)
Ophthalmic Ophthalmic      
Fetal      
Abdominal      
Intra-operative
     
(Specify*)
Intra-operative (Neuro)      
Laparoscopic      
Pediatric      
Small Organ (Specify**)      
Neonatal Cephalic      
Fetal Adult Cephalic      
Imaging &
Other Trans-rectal N N N  N N N Note 1, 2, 4, 5
Trans-vaginal      
Trans-urethral      
Trans-esoph.
     
(non-Card.)
Musculo-skeletal
(Conventional)      

Musculo-skeletal
(Superficial)      

Intravascular      
Cardiac Adult      
Cardiac Pediatric      
Cardiac Intravascular (Cardiac)      
Trans-esoph. (Cardiac)      
Intra-cardiac      
Peripheral Peripheral vessel      
vessel Other (Specify***) N N N  N N N Note 1, 2, 4, 5
N=new indication˗P=previously cleared by FDA˗ E=added under Appendix E
Additional comments˖Combined modes--B+MǃPW+BǃColor + BǃPower + BǃPW +Color+ BǃPower + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: Biopsy Guidance
Note 6: Elastography
Note 7: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)

Page10of10

010-10
 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in

accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan,
Shenzhen, 518057, P. R. China

Tel: +86 755 8188 5082

Fax: +86 755 2658 2680

Contact Person:
Jean Lei
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: October 24, 2017

2. Device Name: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound

System
Classification
Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

3. Device Description:
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is a general
purpose, mobile, software controlled, ultrasound diagnostic system. Its function is
to acquire and display ultrasound images in B-mode, M-mode, PW-mode,
Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode,
Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) or
the combined mode (i.e. B/M-Mode).
This system is a Track 3 device that employs an array of probes that include linear
array, convex array and phased array.

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 4. Intended Use:
Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric
patients and neonates. It is intended for use in fetal, abdominal, pediatric, small
organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal,
trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult,
pediatric) , peripheral vessel and urology exams.

5. Comparison with Predicate Devices:

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is comparable
with and substantially equivalent to these predicate devices:
Type Manufacturer Model 510(k) Number
Predicate Device Mindray DC-N3 K140030
Reference device Mindray DC-8 K170277
Reference device Mindray M9 K171034

The DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System employs

the same technology as the predicate devices. All systems transmit ultrasonic
energy into patients, and then perform post processing of received echoes to
generate onscreen display of anatomic structures and fluid flow within the body.
All systems allow for specialized measurements of structures and flow, and
calculations. The subject device also has the same intended uses and basic
operating modes as the predicate devices.
z Subject device DC-30/DC-32/DC-28/DC-26/DC-25 has the same intended uses
as the predicated device DC-N3 (K140030).
Subject Device Predicate device
Items
DC-30/DC-32/DC-28/DC-26/DC-25 DC-N3 (K140030)
Intended DC-30/DC-32/DC-28/DC-26/DC-25 The DC-N3 diagnostic
Use Diagnostic Ultrasound System is ultrasound system is applicable
applicable for adults, pregnant for adults, pregnant women,
women, pediatric patients and pediatric patients and neonates.
neonates. It is intended for use in It is intended for use in
fetal, fetal,
abdominal, abdominal,
pediatric, pediatric,
small organ(breast, thyroid, small organ (breast, thyroid,
testes), testes),
neonatal cephalic, neonatal cephalic,

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 adult cephalic, adult cephalic,
trans-rectal, trans-rectal,
trans-vaginal, trans-vaginal,
musculo-skeletal(conventional), musculo-skeletal(conventional),
musculo-skeletal(superficial), musculo-skeletal(superficial),
cardiac adult, cardiac adult,
cardiac pediatric, cardiac pediatric,
peripheral vessel, peripheral vessel and urology
and urology exams. exams.
z The patient contact materials of the transducers are tested under ISO
10993-1.
z The acoustic power levels of the DC-30/DC-32/DC-28/DC-26/DC-25 are
below the limits of FDA, which are the same as the predicated device DC-N3
(K140030).
z DC-30/DC-32/DC-28/DC-26/DC-25 is designed in compliance with the FDA
recognized electrical and physical safety standards, which are the same as
the predicated device DC-N3 (K140030).
z Modes and features
„ The DC-30/DC-32/DC-28/DC-26/DC-25 has the same imaging modes as
the predicated device including B mode, M mode, Color mode,
Power/DirPower mode, PW mode and Free Xros M (Anatomical M mode).
„ The DC-30/DC-32/DC-28/DC-26/DC-25 has the same special features as
the predicate device including Static 3D, Smart 3D, 4D, iPage, iScape
View, IMT and iScanHelper.
„ The DC-30/DC-32/DC-28/DC-26/DC-25 share the same options as the
predicate device except Ultrasound gel warmer and IVF, which are the
same as the reference device.
„ Measurements of the subject device are the same as the predicate device
except MAD, which is the same as the reference device.
„ Following features of subject device DC-30/DC-32/DC-28/DC-26/DC-25
are the same as the reference devices.
Items Reference device
Contrast imaging for DC-8(K170277)
liver
Elastography
Ultrasound gel warmer
IVF
MAD measurement M9(K171034)

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z Transducers
„ 35C50P of DC-30/DC-32/DC-28/DC-26/DC-25 has new indication of
contrast imaging for liver as compared to predicate device; however, this
feature is the same as the feature on the reference device
DC-8(K170277).
„ 75L38P of DC-30/DC-32/DC-28/DC-26/DC-25 has new indication of
elastography as compared to predicate device; however, this feature is
the same as the feature on the reference device DC-8(K170277).

6. Non-clinical Tests:
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System has been
evaluated for acoustic output, biocompatibility, cleaning and disinfection
effectiveness as well as thermal, electrical and mechanical safety, and has been
designed to conform with applicable medical safety standards.
Non-clinical tests relied on in this premarket notification submission for a
determination of substantial equivalence include testing showing compliance with
the following standards:
„ AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and
a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1:
general requirements for basic safety and essential performance (iec
60601-1:2005, mod).
„ IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2:
general requirements for basic safety and essential performance - collateral
standard: electromagnetic compatibility - requirements and tests.
„ IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37:
particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment.
„ AAMI / ANSI / IEC 62304:2006, medical device software - software life cycle
processes.
„ AAMI / ANSI / IEC 62366:2007/(R)2013:Medical devices - application of
usability engineering to medical devices
„ IEC 60601-1-6 Edition 3.1 2013-10: medical electrical equipment - part 1-6:
general requirements for basic safety and essential performance - collateral
standard: usability.
„ ISO 14971 Second edition 2007-03-01, medical devices - application of risk
management to medical devices.
„ NEMA UD 2-2004 (R2009), acoustic output measurement standard for
diagnostic ultrasound equipment revision 3.
„ AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical

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 devices - part 1: evaluation and testing within a risk management process.
„ NEMA UD 3 Standard for Real Time Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic Ultrasound Equipment
These non-clinical tests relied on in this premarket notification submission can
support the determination of substantial equivalence of the subject device.

7. Clinical Studies
Not applicable. The subject of this submission,
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System, does not
require clinical studies to support substantial equivalence.

Conclusion:
Intended uses and other key features are consistent with traditional clinical
practices,
FDA guidelines and established methods of patient examination. The design,
development and quality process of the manufacturer confirms with 21 CFR 820,
ISO 9001 and ISO 13485 quality systems. The device conforms to applicable
medical device safety standards. Therefore, the
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is substantially
equivalent with respect to safety and effectiveness to devices currently cleared for
market.

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