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

• K Number: K171034
• 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
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K093713 , K970514 , K152543 , K170277 , K162267
• Predicate For: K200001 , K210416

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.

AI/ML Overview

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System. It describes the device, its intended use, modifications from a previously cleared device, and a comparison with predicate devices.

However, it does not contain acceptance criteria for specific device performance metrics or a study explicitly proving the device meets quantitative acceptance criteria. Instead, it states that the device was evaluated for certain aspects and conforms to applicable medical safety standards, which forms the basis for its substantial equivalence to predicate devices already on the market.

Here's an attempt to answer your questions based on the provided text, recognizing that much of the specific performance data against acceptance criteria is not detailed.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance and specific reported performance values against them. Instead, it relies on the concept of "substantial equivalence" to previously cleared devices (K152543, K170277, K162267). The general statement is that "M9/M9T/M9CV/M8 Elite has the same performance specification as the predicate device M9/M9T/M9CV (K152543) except adding 4D Function, Smart 3D, Smart Volume, iPage and Contrast imaging (Contrast agent for Liver). New added functions are substantial equivalent with the predicates DC-8 (K170277)."

The core "acceptance criteria" appear to be compliance with various recognized medical safety standards and being "substantially equivalent" to predicate devices for its intended uses and performance.

Acceptance Criteria (Inferred)	Reported Device Performance (Summary)
Acoustic Output Measurement compliant with UD 2 Standard	Evaluated for acoustic output, below FDA limits.
Compliance with UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices	Evaluated for thermal and mechanical acoustic output, compliant.
Basic Safety and Essential Performance compliant with AAMI/ANSI ES60601-1	Designed and evaluated for basic safety and essential performance.
Electromagnetic Compatibility compliant with AAMI/ANSI/IEC 60601-1-2	Designed and evaluated for EMC compliance.
Usability compliant with IEC 60601-1-6 and IEC 62366	Designed and evaluated for usability.
Requirements for Ultrasonic Medical Diagnostic and Monitoring Equipment compliant with IEC 60601-2-37	Designed and evaluated for specific requirements of ultrasonic equipment.
Risk Management compliant with ISO 14971	Application of risk management to medical devices.
Biocompatibility compliant with ISO 10993-1 (for new transducers)	Patient contact materials of new transducers tested under ISO 10993-1.
Software Life Cycle Processes compliant with IEC 62304	Software life cycle processes conform to IEC 62304.
Performance specifications equivalent to predicate device K152543 (for existing features)	"Same performance specification as the predicate device"
Performance of new features (4D, Smart 3D, Smart Volume, iPage, Contrast imaging) equivalent to predicate device K170277	"New added functions are substantial equivalent with the predicates DC-8 (K170277)."
Performance of new measurement/calculation functions (healthy fetus weight algorithm, FG and GA formula of fetal foot length, MAPSE, LV and RV of FAC) equivalent to predicate device K162267	"New added features are substantial equivalent with the predicates Resona 7 (K162267)."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "Not applicable. The subject of this submission, M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This implies no specific clinical "test set" in the sense of patient data was used for a new clinical study to demonstrate performance. The evaluation was based on non-clinical tests and comparison to predicate devices. Therefore, there's no information on sample size, country of origin, or retrospective/prospective nature of a clinical data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Given the statement that "clinical studies" were "Not applicable," there's no information about experts used to establish ground truth from a clinical test set. The assessment relied on engineering and quality control evaluations, and comparison to already approved devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

As no specific clinical test set was used, there is no adjudication method mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted or mentioned. The device described is a diagnostic ultrasound system, which produces images and calculations, but the document does not indicate it incorporates AI for interpretation or reader assistance. Therefore, there's no information on human reader improvement with/without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is an ultrasound system. While it has computation features, these are integrated into the diagnostic workflow rather than being a standalone algorithm for independent diagnosis. The document does not describe any standalone algorithm performance testing in the absence of a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests performed (acoustic output, biocompatibility, electrical safety, etc.), the "ground truth" would be established by compliance with recognized standards and regulatory limits. For the "substantial equivalence" argument, the ground truth is implicitly the established safety and effectiveness of the predicate devices. There's no mention of pathology or outcomes data from new studies.

8. The sample size for the training set

No training set is mentioned as no new clinical study or AI algorithm requiring specific training data is described in the provided document. The device is evaluated for substantial equivalence to existing predicate devices.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not applicable/provided.

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 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.

{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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K171034

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

Indications for Use (Describe)

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.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

s [phone]

B

{3}------------------------------------------------

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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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	ColorDoppler	AmplitudeDoppler	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
Peripheralvessel	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

{4}------------------------------------------------

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)

{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}------------------------------------------------

Transducer: P7-3Ts

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

{8}------------------------------------------------

Transducer: SP5-1s

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}------------------------------------------------

Transducer: L14-6Ns

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:

{13}------------------------------------------------

Transducer: CW5s

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

{14}------------------------------------------------

Transducer: C6-2Gs

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

{15}------------------------------------------------

Transducer: L14-6Ws

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

{16}------------------------------------------------

Transducer: P7-3s

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

{17}------------------------------------------------

Transducer: L10-3s

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

{18}------------------------------------------------

Transducer: L16-4Hs

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

{19}------------------------------------------------

Transducer: P8-3Ts

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

{20}------------------------------------------------

Transducer: L20-5s

Clinical Application		Mode of Operation
General	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
(Track 1 Only)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,8
	Neonatal Cephalic
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 1,2,6,8
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1,2,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,8
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K161525);							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	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1,2,4,9
	Abdominal	N	N	N		N	N	N	Note 1,2,4,9
	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)
	Intra-cardiac
Peripheralvessel	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)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

{21}------------------------------------------------

Transducer: D7-2s

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

{22}------------------------------------------------

Transducer: L14-5sp

	Clinical Application						Mode of Operation
General(Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,8
	Intra-operative (Specify*)	P	P	P		P	P	P	Note 1,2,8
	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 1,2,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,8
	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
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,8
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K161525); 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)

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

{23}------------------------------------------------

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: K171034

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:

Ma Chao 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: March 29, 2017

2. Device Name: M9/M9T/M9CV/M8 Elite 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/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

Image /page/23/Picture/14 description: The image shows the number 002-1 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 2 and the 1.

{24}------------------------------------------------

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.

4. 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, 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. Summary of Modifications and New Added Features

This submission device is a modification to M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System previously cleared in K152543.

The following is a brief overview of the modifications and new added features.

• New added transducers L16-4Hs, P8-3Ts, L20-5s, D7-2s and L14-5sp
• . New added needle-guided bracket CIVCO 658-001, CIVCO 610-543 and CIVCO 610-1274
• New added model M8 Elite
• New added features . 4D Function Smart 3D Smart Volume iPage Contrast imaging (Contrast agent for Liver) Healthy fetus weight algorithm to obstetric measurement FG and GA formula of fetal foot length MAPSE measurement in the M mode LV and RV of FAC calculation

6. Comparison with Predicate Devices:

M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Control Number
------------------	--------------	-------	-----------------------

{25}------------------------------------------------

1	Mindray	M9/M9CV/M9T(Main predicate device)	K152543
2	Mindray	DC-8	K170277
3	Mindray	Resona 7	K162267

Compared to the predicate devices M9/M9CV/M9T (K152543):

• M9/M9T/M9CV/M8 Elite 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 L16-4Hs, P8-3Ts, L20-5s, D7-2s and L14-5sp. All of the new added probes are substantial equivalent with the predicate DC-8 (K170277).
• The patient contact materials of the new added transducers are tested under ISO 10993-1.
• The newly added needle-guided bracket that was purchased from CIVCO MEDICAL INSTRUMENTS CO., INC. be cleared along with CIVCO 658-001 (K093713), CIVCO 610-543 (K970514) and CIVCO 610-1274 (K970514).
• 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/M8 Elite has the same capability in term of measurements and calculation functions except adding healthy fetus weight algorithm, FG and GA formula of fetal foot length. MAPSE measurement in the M mode and LV and RV of FAC calculation. New added features are substantial equivalent with the predicates Resona 7 (K162267).
• M9/M9T/M9CV/M8 Elite has the same performance specification as the predicate device M9/M9T/M9CV (K152543) except adding 4D Function, Smart 3D, Smart Volume, iPage and Contrast imaging (Contrast agent for Liver). New added functions are substantial equivalent with the predicates DC-8 (K170277).

7. Non-clinical Tests:

M9/M9T/M9CV/M8 Elite 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.

{26}------------------------------------------------

• Standard for Real Time Display of Thermal and Mechanical Acoustic UD 3 Output Indices on Diagnostic Ultrasound Equipment
• AAMI/ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• AAMI/ANSI/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 60601-1-6 Medical electrical equipment - part 1-6: general requirements forbasic safety and essential performance - collateral standard: usability
• 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
• Medical devices - Application of risk management to medical ISO 14971 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
• IEC 62366 Medical devices - Application of usability engineering to medical devices

These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

8. Clinical Studies

Not applicable. The subject of this submission, M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the M9/M9T/M9CV/M8 Elite Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.