M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K141010
• Device Name: M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD
• Date Cleared: 2014-05-14 ( 26 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K132341 , K131690 , K101236
• Predicate For: K143472 , K150080 , K152543 , K152763

Intended Use

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

Device Description

M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, PW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.

AI/ML Overview

The provided text describes a 510(k) summary for the Mindray M9/M9T/M9CV Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or extensive study results typical of novel AI/ML device submissions.

Therefore, much of the requested information (acceptance criteria, specific study results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not present in the provided document.

However, based on the non-clinical tests mentioned, we can infer the acceptance criteria for certain parameters, and the document explicitly states that clinical studies were not applicable.

Here's a breakdown of what can be extracted and what information is missing:

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1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound system demonstrating substantial equivalence to predicate devices, direct "acceptance criteria" and "reported device performance" in the context of a new algorithm's efficacy are not explicitly stated in a quantitative table format. Instead, the acceptance is implied by adherence to general safety and performance standards for ultrasound systems and comparable features to predicate devices.

Acceptance Criteria Category (Inferred)	Reported Device Performance / Compliance
Acoustic Output Limits	Below the limits of FDA (same as predicate DC-8)
Biocompatibility	ISO 10993-1 for SP5-1s probe materials; same as predicate DC-8 and M7 for other patient contact materials
Cleaning and Disinfection Effectiveness	Evaluated (details not provided, but implies compliance)
Thermal Safety	Designed to conform with applicable medical safety standards
Electrical Safety	Designed to conform with applicable medical safety standards
Mechanical Safety	Designed to conform with applicable medical safety standards
Electrical and Physical Safety Standards	Designed in compliance with FDA recognized standards (same as predicate DC-8)
Electromagnetic Compatibility	IEC 60601-1-2 (Edition 3) compliant
Usability Engineering	IEC 62366 compliant
Software Life Cycle Processes	IEC 62304 compliant
Risk Management	ISO 14971 compliant
Imaging Modes	Same as predicate DC-8 (B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Color M, Anatomical M Mode, combined mode)
Special Functions	Identical to predicate DC-8 (iScape, TDI, TDI QA, LVO, Elastography, Stress Echo, Tissue Tracking QA, iWorks, iNeedle and IMT)
Measurement and Calculation Functions	Same as predicate DC-8, except cardiac MV ALL equivalent to predicate Voluson E8

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

Not applicable/Not provided. The submission explicitly states "Clinical Studies: Not applicable. The subject of this submission, M9/M9T/M9CV Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This means there was no test set of patient data in the context of demonstrating clinical efficacy for a new algorithm or diagnostic capability. The evaluation relied on non-clinical engineering and safety standards, and comparison of features to already cleared predicate devices.

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)

Not applicable/Not provided. As no clinical studies or a test set requiring ground truth were conducted, this information is not relevant to this submission.

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

Not applicable/Not provided. No test set was used for clinical performance evaluation.

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

Not applicable/Not provided. This is a clearance for a diagnostic ultrasound system, not a specific AI-powered diagnostic algorithm requiring a comparative effectiveness study of human readers.

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

Not applicable/Not provided. This is not an AI/ML algorithm submission in that sense. The device is a diagnostic ultrasound system.

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

Not applicable/Not provided. No test set requiring ground truth was used for clinical performance evaluation. The "ground truth" for this submission largely refers to engineering specifications, safety standards, and functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of an algorithm development or training phase with a specific training set to establish new diagnostic capabilities. The device's functionalities (e.g., iScape, Elastography) are listed as "identical" to or "similar" to those in predicate devices, implying their performance was established previously or is inherent to the system's design and physics.

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

Not applicable/Not provided. As there is no explicitly mentioned training set, there is no information on how its ground truth would have been established.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is:

1. Submitter:

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

Tel: [phone] Fax: [phone]

Contact Person:

Wu Zicui

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

Date Prepared: February 19, 2014

2. Device Name: M9/M9T/M9CV Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

3. Device Description:

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

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

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MHz.

4. Intended Use:

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

5. Comparison with Predicate Devices:

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

Predicate Device	Manufacturer	Model	510(k) Number
1	Mindray	DC-8	K132341
2	Mindray	M7	K131690
3	GE	Voluson E8	K101236

M9/M9T/M9CV has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and 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.

• Subject device M9/M9T/M9CV has the same intended uses as the predicated device ● DC-8(K132341)

Subject Device	Predicate device
M9/M9T/M9CV	DC-8 (K132341)
The M9/M9CV/M9T Diagnostic UltrasoundSystem is applicable for adults, pregnantwomen, pediatric patients and neonates. It isintended for use in fetal, abdominal, pediatric,small organ(breast, thyroid, testes), neonataland adult cephalic, trans-rectal, trans-vaginal,musculo-skeletal(conventional, superficial),adult and pediatric cardiac,trans-esoph.(Cardiac), peripheral vessel ,urology exams.	The DC-8/DC-8 PRO/DC-8 CV/DC-8EXP/DC-8S diagnostic ultrasound system isapplicable for adults, pregnant women, pediatricpatients and neonates. It is intended for use infetal, abdominal, pediatric, small organ (breast,thyroid, testes), neonatal cephalic, adultcephalic, trans-rectal, trans-vaginal,musculo-skeletal (conventional, superficial),cardiac adult, cardiac pediatric, peripheralvessel, urology and transesophageal (Cardiac)exams

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• All of the patient contact material of the M9/M9T/M9CV are the same as that of the predicated device DC-8(K132341) and the predicated device M7(K131690) with the exception of the materials for probe SP5-1s. Materials for the SP5-1s are tested under ISO 10993-1 for its biocompatibility.
• The acoustic power levels of M9/M9T/M9CV are below the limits of FDA, which is the same as the predicated device DC-8(K132341).
• M9/M9T/M9CV is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-8(K132341).
• M9/M9T/M9CV has the same imaging modes as the predicated device DC-8(K132341): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Color M, Anatomical M Mode and combined mode).
• M9/M9T/M9CV has some special functions: iScape, TDI, TDI QA, LVO, Elastography, Stress Echo, Tissue Tracking QA, iWorks, iNeedle and IMT. All of them are identical as the predicated device DC-8(K132341).
• M9/M9T/M9CV has the same capacity in term of making comments and body marks on the images, reporting patient exam results as the predicated device DC-8(K132341).
• . M9/M9T/M9CV has similar probes as the predicated device DC-8(K132341) and M7(K131609):

Subject device	Predicated device	Predicated device	NOTE
M9/M9T/M9CV	DC-8(K132341)	M7(K131690)
C5-1s	C5-2E	/	They have same indications for use, mode of operation, array elements. Different design is intended to improve penetrability and spacial resolution. C5-1s probe has been tested under the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Differences do not influence the safety and effectiveness of this probe.
L12-4s	/	L12-4s	Same.
P10-4s	P10-4E	/	Same (except for the shape of the socket which does not affect the performance of the probe).
P7-3Ts	/	P7-3Ts	Same.

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L14-6Ns		L14-6Ns	Same.
V11-3Ws	V11-3WE	/	Same (except for the shape-of the socket which doesnot affect the performanceof the probe).
C11-3s	C11-3E	/	Same (except for the shapeof the socket which doesnot affect the performanceof the probe).
CW2s	CW2s	/	Same.
CW5s	CW5s	/	Same.
SP5-1s	P4-2NEP4-2E	/	SP5-1s has the sameindications for use andperformance specificationwith P4-2NE, except thatindications for use NeonatalCephalic is substantially

. M9/M9T/M9CV has the same measurement and calculation functions as the predicated device DC-8(K132341) except for the cardiac measurement and calculation MV ALL which is equivalent to predicated device Voluson E8(101236).

6. Non-clinical Tests:

M9/M9T/M9CV Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

• UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound . Equipment.
• UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 통 AAMI / ANS1 ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• 를 IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
• IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• ISO14971 Medical devices Application of risk management to medical devices B
• ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and

0.5

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K141010
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testing within a risk management process

• 에 IEC 62366 Medical devices - Application of usability engineering to medical devices
• l Medical device software - Software life cycle processes IEC 62304

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

7. Clinical Studies

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

Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 14, 2014

Shenzhen Mindray Bio-Medical Electronics, Co. Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Scrvices LLC 1394 25" Street NW BUFFALO MN 55313

Re: K141010

Trade/Device Name: M9 Diagnostic Ultrasound System. M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: 11 Product Code: IYN, IYO, ITX Dated: April 24, 2014 Received: April 25, 2014

Dear Mr. Job:

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: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9C V Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

C11-3s	C5-1s	L12-4s
P7-3Ts	SP5-1s	P10-4s
L14-6Ns	V11-3Ws	CW2s
CW5s

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Page 2-Mr. Job

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safety/ReportalProblem/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,

for

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K141010

Device Name M9/M9T/M9CV

Indications for Use (Describe)

The M91M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), adult and pediatic cardiac, trans-soph.(Cardiac), peripheral vessel, urology exams.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Page 1 of 2

008-I
PSC Publishing Services (30); 441-4740 EF

FORM FDA 3881 (1/14)

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Diagnostic Ultrasound Indications For Use Format

M9/M9T Diagnostic Ultrasound System System:

Transducer: N/A

Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N	N	N	N	N	Note 1, 2,4,5
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2,5,6
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5
	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,5
	Trans-rectal	N	N	N	N	N	N	N	Note 1,2,4,5
	Trans-vaginal	N	N	N	N	N	N	N	Note 1, 2,4,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	Note 1,2,4,5
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N	Note 1,2,5
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,3,4,5,7
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,3,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N	Note 1, 3,4
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2,4,5
	Other (Specify***)	N	N	N	N	N	N	N	Note 1,2,4,5
	N=new indication: P=previously cleared by FDA E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	* Intraoperative includes abdominal, thoracic, and vascular.
	** 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
		Notes: Biopsy Guidance
		Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
		Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application						Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,4,5
	Small Organ (Specify**)
Fetal Imaging& Other	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2,4,5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric	N	N	N		N	N	N	Note 1,2,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,4,5
	Other (Specify***)
	N=new indication; P=previously cleared by FDA					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、								Power + PW +B.
	* Intraoperative includes abdominal, thoracic, and vascular etc.
	** Small organ-breast, thyroid, testes.
	*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: iScape
Note 3:TDI
Note 4: Color M
Note 5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application						Mode of Operation
General(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Only)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1.2.4.5
	Abdominal	N	N	N		N	N	N	Note 1,2,4,5
	Intra-operative (Specify®)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,4,5
	Small Organ (Specify**)
Fetal Imaging	Neonatal Cephalic
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal	N	N	N		N	N	N	Note 1,2,4,5
	(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	N	N	ਮ		N	N	N	Note 1,2,4,5
vesse.	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、PW +Color+B、PW +Color+B、PW+B.
	* Intraoperative includes abdominal, thoracic, and vascular.
	* * Small organ-breast, thyroid, testes.
	*** Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application	Mode of Operation
General(Track 1Only)	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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1.2,5
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,5,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,5
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1.2,5
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
	Other (Specify***)
	N=new indication: P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
	* Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	*** Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application			Mode of Operation
General(Track IOnly)	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 Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	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.
** Small organ-breast, thyroid, testes.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application						Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,5
	Small Organ (Specify **)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5
Fetal Imaging& Other	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,3,4,5,7
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2,3,4,5
Cardiac	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.
	** Small organ-breast, thyroid, testes.
	*** Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
	Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application						Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)		B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		N	N	N	N	N	N	N	Note 1,4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		N	N	N	N	N	N	N	Note 1,4
	Small Organ (Specify**)
	Neonatal Cephalic		N	N	N	N	N	N	N	Note 1,4
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 Pediatric		N	N	N	N	N	N	N	Note 1, 3,4
Cardiac	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.
	**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
Note 5: Biopsy Guidance
Note 6: Elastography
	Note 7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

{10}------------------------------------------------

M9/M9T Diagnostic Ultrasound System System: Transducer: C11-3s

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

Prescription USE (Per 21 CFR 801.109)

.

ﻟ

{11}------------------------------------------------

System: M9/M9T Diagnostic Ultrasound System Transducer: CS-Is

.

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

{12}------------------------------------------------

M9/M9T Diagnostic Ultrasound System System:

Transducer: L 12-4s

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

Image /page/12/Picture/5 description: The image shows the text '008-6' in bold font at the top. Below that, the text 'Page 6 of 13' is printed in a smaller, regular font. The text indicates that this is page 6 of a document that is 13 pages long and the document number is 008-6.

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

M9/M9T Diagnostic Ultrasound System System:

Transducer: P7-3Ts

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

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

M9/M9T Diagnostic Ultrasound System System: Transducer: SPS-Is

Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:

Prescription USE (Per 21 CFR 801.109)

・

Image /page/14/Picture/4 description: The image shows the text "OOS-8" in a bold, sans-serif font. Below this, the text "Page 8 of 13" is printed in a smaller, serif font. The text indicates that this is page 8 of a document that has 13 pages total.

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

M9/M9T Diagnostic Ultrasound System System: Transducer: P 10-4s

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

.

Image /page/15/Picture/4 description: The image shows the text "008-9" in bold font on the top line. Below that, the text "Page 9 of 13" is printed in a smaller, regular font. The text indicates a page number within a document.

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

M9/M9T Diagnostic Ultrasound System System: Transducer: L 14-6Ns

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

Clinical Application		Mode of Operation
General(Track IOnly)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude CombinedDoppler	(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5
	Intra-operative (Specify®)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Nole 1,2,5
	Small Organ (Specify* * )	P	P	P		P	P	P	Note 1,2,5.6
	Neonatal Cephalic	p	P	P		P	P	P	Note 1,2,5
Fetal Imaging	Adult Cephalic
& Other	Trans-recial
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal	ক	P	P		P	P	P	Note 1.2.5
	(Conventional)
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,5
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
vessel	Other (Specify *** )
	N=new indication; P=previously cleared by FDA					E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、								Power + PW +B.
	* Intraoperative includes abdominal, thoracic, and vascular.
	** 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
Notes: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application	Mode of Operation
General(Track IOnly)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1,2,4,5
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1,2,4,5
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2.4.5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify *** )	N	N	N		N	N	N	Note 1,2,4,5
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3: TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application			Mode of Operation
General(Track 1Only)	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				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult				P
	Cardiac Pediatric				P
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel				P
	Other (Specify***)
	N=new indication; P=previously cleared by FDA					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	* Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application			Mode of Operation
General(Track IOnly)	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 Adult
	Cardiac Pediatric				P
Cardiac	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.
	** 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 I.VO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

M9/M9T Diagnostic Ultrasound System System:

VII-3Ws Transducer:

Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:

Image /page/17/Picture/5 description: The image shows the text "008-11" in bold font, followed by the text "Page 11 of 13" in a smaller, regular font. The text appears to be part of a document or report, indicating a page number and total number of pages. The numbers suggest that this is page 11 of a 13-page document.

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

System: M9/M9T Diagnostic Ultrasound System Transducer: CW2s

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

.

Prescription USE (Per 21 CFR 801.109)

.

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

System: M9/M9T Diagnostic Ultrasound System Transducer: CW5s

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

Prescription USE (Per 21 CFR 801.109)

008-13 Page 13 of 13

: ·

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.