Predicate Devices

K141010, K150080, K121062, K143472, K150204, K132913

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and post-processing techniques, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound data," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "The M9/M9CV/M9T Diagnostic Ultrasound System" and describes its use for various exams, indicating its purpose is for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasonic diagnostic system" that employs "an array of probes" with a specific frequency range. This indicates the device includes hardware components (probes) for acquiring ultrasound data, in addition to the software control and processing.

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 M9/M9CV/M9T Diagnostic Ultrasound System uses ultrasound waves to create images of internal anatomical structures and fluid flow within the body. It does not analyze samples taken from the body.
Intended Use/Indications for Use: The intended uses listed are all related to imaging internal parts of the body (fetal, abdominal, cardiac, etc.). There is no mention of analyzing biological samples.
Device Description: The description focuses on the ultrasound technology, imaging modes, and probes used to acquire and display ultrasound data.

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

The M9/M9CV/M9T 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), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel , urology exams.

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

IYN, IYO, ITX

Device Description

M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).

This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.

Mentions image processing

Not Found

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, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, 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 were performed for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical and mechanical safety. The device conforms to applicable medical safety standards. Clinical studies were not required to support substantial equivalence.

Key Results:

M9/M9T/M9CV 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.
This device has been tested and evaluated under the following standards:
- UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AAMI / ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- ISO14971 Medical devices - Application of risk management to medical devices
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- IEC 62304 Medical device software - Software life cycle processes
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

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.

K141010, K150080, K121062, K143472, K150204, K132913

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.

Not Found

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles or a bird in flight, rendered in a dark color.

October 29, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Wu Zicui Engineer of Regulation Technical Department Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 P.R. CHINA

Re: K152543

Trade/Device Name: M9/M9T/M9CV 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: August 27, 2015 Received: September 4, 2015

Dear Wu Zicui:

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

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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)

K152543

Device Name M9/M9T/M9CV

Indications for Use (Describe)

The M9/M9CV/M9T 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), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel , 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)

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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See PRA Statement below.

3

Diagnostic Ultrasound Indications For Use Format

M9/M9T Diagnostic Ultrasound System System:

Transducer: N/A

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

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	P	P	P		P	P	P	Note 1, 2,4,5
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2,5,6
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5
	Trans-rectal	P	P	P	P	P	P	P	Note 1,2,4,5
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 2,4,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,2,4,5
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note 1,2,5
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,7
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1, 3,4
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,4,5
	Other (Specify***)	P	P	P	P	P	P	P	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: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
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
Imaging &
Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,4,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,4,5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P		P	P	P	Note 1,2,4,5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	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: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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	P	P	P		P	P	P	Note 1,2,4,5
	Abdominal	P	P	P		P	P	P	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	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)	P	P	P		P	P	P	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	P	P	P		P	P	P	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: iScape
	Note 3:TDI
	Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
Only)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6
Fetal	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5
Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	P	P	P		P	P	P	Note 1,2,5
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,5
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
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: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

4

Transducer: C11-3s

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

5

Transducer: C5-1s

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

6

Transducer: L12-4s

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

7

M9/M9T Diagnostic Ultrasound System System:

Transducer: P7-3Ts

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

	Clinical Application		Mode of Operation
	General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
	Ophthalmic	Ophthalmic
		Fetal
		Abdominal
		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)	P	P	P	P	P	P	P	Note 1, 3,4
		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: iScape
Note 3:TDI
	Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
	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	P	P	P	P	P	P	P	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,7
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5
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: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)
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	P	P	P	P	P	P	P	Note 1,4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging &
Other	Pediatric	P	P	P	P	P	P	P	Note 1,4
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 3,4
	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: iScape
Note 3:TDI
Note 4:Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

8

SP5-1s Transducer:

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

9

Transducer: P10-4s

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

10

System:	M9/M9T Diagnostic Ultrasound System
---------	-------------------------------------

Transducer: L14-6Ns

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)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	P	P	P		P	P	P	Note 1,2,5
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,5
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
	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: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application	Mode of Operation
	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
General
(Track 1
Only)	Ophthalmic
Ophthalmic	Fetal	P	P	P		P	P	P	Note 1,2,4,5
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,4,5
	Trans-vaginal	P	P	P		P	P	P	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***)	P	P	P		P	P	P	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: iScape
	Note 3: TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

11

Transducer: V11-3Ws

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

12

Transducer: CW2s

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

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				P
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult				P
	Cardiac Pediatric				P
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel				P
	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: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

13

Transducer: CW5s

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

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
Fetal
Imaging &
Other	Pediatric				P
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric				P
	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: iScape
		Note 3:TDI
		Note 4: Color M
		Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application					Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note1,2,4,5
	Abdominal	N	N	N	N	N	N	N	Note1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note1,2,4,5
	Small Organ (Specify**)
Fetal	Neonatal Cephalic
Imaging &	Adult Cephalic
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+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: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	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
Fetal
Imaging &
Other	Abdominal	N	N	N		N	N	N	Note 1,2,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,5,6
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2,5
	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1,2,5
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2,5
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,5
	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: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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	P	P	P	P	P	P	P	Note 1, 2,4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1, 2,4
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,3,4
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: iScape
Note 3:TDI
	Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

Clinical Application			Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
e Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,6
Fetal
Imaging &
Other	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note 1,2
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2
	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
	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: iScape
		Note 3:TDI
		Note 4: Color M
		Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

		Concurrence of CDRH, Office of Device Evaluation(ODE)

14

M9/M9T Diagnostic Ultrasound System System:

Transducer: C6-2Gs

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

15

M9/M9T Diagnostic Ultrasound System System:

Transducer: L14-6Ws

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

16

M9/M9T Diagnostic Ultrasound System System:

Transducer: P7-3s

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

17

M9/M9T Diagnostic Ultrasound System System:

Transducer: L10-3s

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

18

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).

The assigned 510(k) number is:

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 5658 Fax: +86 755 2658 2680

Contact Person:

Wu Zicui 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: August 17, 2015

2. Device Name: M9/M9T/M9CV 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:

M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).

This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0

19

MHz.

4. Intended Use:

The M9/M9CV/M9T 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), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.

5. Comparison with Predicate Devices:

M9/M9T/M9CV Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate
Device | Manufacturer | Model | 510(k)
Control
Number |
|---------------------|------------------|-----------------------------------------------|-----------------------------|
| 1 | Mindray | M9/M9 CV/M9T
(Main predicate
device) | K141010 |
| 2 | Mindray | DC-8/DC-8
PRO/DC-8 CV/DC-8
EXP/DC-8S | K150080 |
| 3 | GE
Healthcare | Vivid q | K121062 |
| 4 | Mindray | TE7 | K143472 |
| 5 | Mindray | DC-70/DC-70T/DC-70
Pro/DC-70
Exp/DC-70S | K150204 |
| 6 | GE
Healthcare | Voluson E8 | K132913 |

Compared to the predicate devices M9/M9 CV/M9T (K 141010):

· M9/M9T/M9CV has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes All systems transmit ultrasonic energy into patients, 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 transducers are same except for adding C6-2Gs, L14-6Ws, P7-3s and L10-3s.

20

All of the new added probes are substantial equivalent with the predicate DC-8(K150080).

It has the system acoustic power level which is below FDA limits and it is designed in compliance with same FDA recognized standards.
· M9/M9T/M9CV has the same capability in term of measurements and calculation functions except adding uterine artery's PI and RI growth curve, new CFEF formula in obstetric and Global Strain curve and peak showed increased. New added features are substantial equivalent with the predicates Vivid q and Voluson E8..
M9/M9T/M9CV has the same performance specification as the predicate device M9/M9T/M9CV K141010 except adding Auto EF, automated scan angle correction function for PW, Q-path and supporting MedTouch. New added functions are substantial equivalent with the predicates Vivid q. DC-70 and TE7.

6. Non-clinical Tests:

M9/M9T/M9CV 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. This device has been tested and evaluated under the following standards:

UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
I UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. AAMI / ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
l IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
. IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
. ISO14971 Medical devices - Application of risk management to medical devices
. ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

. IEC 62304 Medical device software - Software life cycle processes

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, M9/M9T/M9CV Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

21

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 M9/M9T/M9CV Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.