K Number

Device Name

M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Date Cleared

2017-07-10

(95 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

The M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-reginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.

Device Description

M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), 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, convex array and phased array.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152543, K170277, K162267

Reference Devices

K093713, K970514

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for "acquire and display ultrasound data," which are functions of diagnosis, not therapy.

Diagnostic

Yes
The device is explicitly named "M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System" and its intended use is for various exams, which are typically performed for diagnostic purposes. Its function is to acquire and display ultrasound data using multiple modes, which again strongly indicates a diagnostic function.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "general purpose, software controlled, ultrasonic diagnostic system" and mentions employing "an array of probes," which are hardware components.

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 medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System is an "ultrasonic diagnostic system." It acquires and displays ultrasound data by sending sound waves into the body and receiving the echoes. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
Intended Use: The intended uses listed are all procedures performed directly on the patient's body (fetal, abdominal, cardiac, etc.). There is no mention of analyzing samples taken from the body.

Therefore, this device falls under the category of diagnostic imaging systems rather than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

IYN, IYO, ITX

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esophageal (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 included evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical and mechanical safety. The device was designed to conform with applicable medical safety standards and was tested and evaluated under UD 2, UD 3, AAMI/ANSI ES60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, and IEC 62366. Clinical studies were not required to support substantial equivalence.

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.

K152543, K170277, K162267

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.

K093713, K970514

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

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 a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

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. % Mr. Chao Ma Engineer of Technical Regulation Department Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057 Guangdong P R CHINA

July 10, 2017

Re: K171034

Trade/Device Name: M9/M9CV/M9T/M8 Elite 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: June 19, 2017 Received: June 21, 2017

Dear Mr. Ma:

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.

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. 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

Indications for Use

510(k) Number (if known)

K171034

Device Name M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

✔ 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)

s (301) 443-6740

Diagnostic Ultrasound Indications For Use Format

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, 2,4,5,8,9
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,5,8,9,10
	Intra-operative (Specify*)	N	N	N		N	N	N	Note1,2,8
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,8
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6,8
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,8
Fetal Imaging
& Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5,8
	Trans-rectal	P	P	P		P	P	P	Note 1,2,4,5,8
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2,4,5,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,4,5,6,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,5,6,8
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,7,8
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,8
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1, 3,4,8
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,4,5,8
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,4,5,8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
General
(Track 1 Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,4,5,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,4,5,8
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,4,5,8
Fetal Imaging
& Other	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 1,2,4,5,8
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,4,5,8
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D

	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
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 1,2,4,5,8
	Abdominal	P	P	P		P	P	P	Note 1,2,4,5,8,10
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,4,5,8
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P		P	P	P	Note 1,2,4,5,8
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,4,5,8
	(Conventional)
	Musculo-skeletal
(Superficial)
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,4,5,8
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543);						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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: 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)
Clinical Application		Mode of Operation
General	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
(Track 1 Only)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,8
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5,8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,5,6,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,5,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5,8
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: 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)
Clinical Application		Mode of Operation
General	Specific (Track 1 & 3)	B	M	PWD	CWD	Color	Amplitude	Combined	Other (specify)
(Track 1 Only)						Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	b	P	P	P	b	P	P	Note 1, 3,4
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543);						E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +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: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: 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)
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 1,2,4,5,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5,8
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,8
Fetal Imaging
& Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,7,8
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,8
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	Clinical Application	Mode of Operation
General	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
(Track 1 Only)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,4,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,4,8
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,4,8
Fetal Imaging
& Other	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	P	P	P	P	P	P	Note 1, 3,4,8
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: 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)
	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	Note 1,2,5,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,8
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5,8
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,5,6,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,5,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5,8
	Other (Specify***)
	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 1,2,4,5,8
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,4,5,8
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,4,5,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,4,5,8
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel				P
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging
& Other	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(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(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	Note1,2,4,5,8
	Abdominal	P	P	P		P	P	P	Note1,2,4,5,8,10
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note1,2,4,5,8
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
		Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(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 1,2,5,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,8
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5,8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,5,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,5,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5,8
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(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, 2,4,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,8
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,8
Fetal Imaging
& Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1, 2,4,8
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,3,4,8
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,3,4,8
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152543); 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)
Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)

	(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	Note 1,2,8
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,8
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,8
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,8
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K152543); 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)
Note8: Smart 3D
Note9: 4D(Real-time 3D)
Note10: Contrast imaging (Contrast agent for Liver)
(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	N	N	N		N	N	N	Note1,2,8
	Intra-operative (Specify*)	N	N	N		N	N	N	Note1,2,8
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note1,2,8
	Small Organ (Specify**)	N	N	N		N	N	N	Note1,2,8
	Neonatal Cephalic	N	N	N		N	N	N	Note1,2,8
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	N	Note1,2,8
	Musculo-skeletal
(Superficial)	N	N	N		N	N	N	Note1,2,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	Note1,2,8
	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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N	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)
	Note8: Smart 3D
	Note9: 4D(Real-time 3D)
	Note10: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System System: Transducer: N/A

Note10: Contrast imaging (Contrast

Transducer: C11-3s

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Transducer: C5-1s