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

• K Number: K173369
• Device Name: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
• Manufacturer: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd
• Date Cleared: 2017-12-13 ( 47 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

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.

Predicate Devices

K140030

Reference Devices

K170277, K171034

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging modes and post-processing techniques, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies section lists compliance with standard medical device and ultrasound standards, not AI/ML specific validation.

Therapeutic

No
The device is explicitly described as a "Diagnostic Ultrasound System" and its intended use is to "acquire and display ultrasound images," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Ultrasound System" and lists various medical exams it is intended for, which are diagnostic in nature. The "Device Description" also refers to it as an "ultrasound diagnostic system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and a "general purpose, mobile, software controlled, ultrasound diagnostic system." It also mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound images. The performance studies also include standards related to electrical safety and acoustic output, further indicating the presence of hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound technology uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
• Intended Use: The intended use describes imaging various anatomical sites within the body, not analyzing biological samples.
• Device Description: The description focuses on the imaging modes and capabilities of the ultrasound system.
• Lack of IVD-related information: There is no mention of reagents, assays, sample handling, or any other components or processes typically associated with in vitro diagnostics.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel and urology

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Clinical studies are not applicable as the device does not require clinical studies to support substantial equivalence.

Key results: The device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140030

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K170277, K171034

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

December 13, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % 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 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);

1

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K173369

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, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

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

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

3

Transducer:

Clinical Application	Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitud
e Doppler	Combined
(specify)	Other (specify)
Ophthalmi
c	Ophthalmic
	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
Imaging &
Other	Adult Cephalic	N	N	N		N	N	N	Note 1, 2, 4, 5
	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
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4, 5
	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+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + 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)
Clinical Application			Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
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**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	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
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4, 5
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;									E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + 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)
Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
	Ophthalmic
	Fetal
Fetal
Imaging &
Other	Abdominal	N	N	N		N		N	Note 1, 2, 4, 5
	Intra-operative
(Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N		N	Note 1, 2, 4, 5
	Small Organ (Specify**)	N	N	N		N		N	Note 1, 2, 4, 5, 6
	Neonatal Cephalic	N	N	N		N		N	Note 1, 2, 4, 5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N		N	Note 1, 2, 4, 5, 6
	Musculo-skeletal
(Superficial)	N	N	N		N		N	Note 1, 2, 4, 5, 6
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N		N	Note 1, 2, 4, 5
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + 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)
Clinical Application			Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
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
Imaging &
Other	Adult Cephalic
	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+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + 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)
Clinical Application			Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
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
Imaging &
Other	Adult Cephalic	N	N	N		N	N	N	Note 1, 2, 4, 5
	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
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4, 5
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;								E=added under Appendix E
	*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)

4

Transducer: 35C50P

5

Transducer: 75L38P

6

Transducer: 6CV1P

7

Transducer: 6C2P

Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Page 6 of 10

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Transducer: D6-2P

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
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**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	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
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + 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)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
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
Fetal
Imaging &	Neonatal Cephalic	N	N	N		N	N	N	Note 1, 2, 4, 5
Other	Adult Cephalic
	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
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4, 5
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + 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)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
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**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	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
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4, 5
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;							E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + 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)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
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***)	Z	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+M、PW+B、Color + B、PW +Color+B、Power + 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)

9

Transducer: 7L4P

10

Transducer: 3C5P

11

Transducer: CB10-4P

12

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: [phone] Fax: [phone]

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.

• . Subject device DC-30/DC-32/DC-28/DC-26/DC-25 has the same intended uses as the predicated device DC-N3 (K140030).

| Items | Subject Device
DC-30/DC-32/DC-28/DC-26/DC-25 | Predicate device
DC-N3 (K140030) |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | DC-30/DC-32/DC-28/DC-26/DC-25
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 cephalic, | The DC-N3 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 cephalic, |

14

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,
and urology exams.	peripheral vessel and urology
exams.

• The patient contact materials of the transducers are tested under ISO 10993-1.
• 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).
• 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).
• 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
liver	DC-8(K170277)
Elastography
Ultrasound gel warmer
IVF
MAD measurement	M9(K171034)

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• 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

16

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 quidelines 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.