TE7/TE5 Diagnostic Ultrasound System

• K Number: K180912
• Device Name: TE7/TE5 Diagnostic Ultrasound System
• Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd
• Date Cleared: 2018-07-30 ( 115 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid. testes), neonatal and adult cephalic. trans-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

Device Description

TE7/TE5 is a 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, LVO, Color M, Smart 3D, TDI 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.

Predicate Devices

K161525

Reference Devices

K171891, K163690, K140254, K171233, K171034

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.

Therapeutic

No

Explanation: The device is described as a "Diagnostic Ultrasound System" intended for acquiring and displaying ultrasound data for various exams. Its purpose is for diagnosis, not therapy.

Diagnostic

Yes

The device's description explicitly states "TE7/TE5 is a software controlled, ultrasonic diagnostic system." Additionally, its intended use and the various imaging modes (B-Mode, M-Mode, PW-Mode, etc.) are characteristic of diagnostic imaging equipment. The predicate device's name also includes "Diagnostic Ultrasound System".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasonic diagnostic system" that "employs an array of probes," which are hardware components. While it is software-controlled, it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The TE7/TE5 Diagnostic Ultrasound System is described as a software-controlled ultrasonic diagnostic system. It uses ultrasound waves to create images of internal structures of the body.
• Intended Use/Indications for Use: The intended uses listed are all related to imaging various anatomical sites within the body using ultrasound. There is no mention of analyzing samples taken from the body.
• Device Description: The description focuses on the ultrasound technology and imaging modes.
• Lack of IVD-related information: There is no mention of reagents, assays, sample handling, or any other elements typically associated with IVD devices.

Therefore, the TE7/TE5 Diagnostic Ultrasound System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid. testes), neonatal and adult cephalic. trans-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

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

IYN, IYO, ITX

Device Description

TE7/TE5 is a 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, LVO, Color M, Smart 3D, TDI 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), Pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-esophageal (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Non-clinical Tests: TE7/TE5 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 found to conform with applicable medical safety standards. Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. AAMI / ANSI / IEC 62304:2006, medical device software software life cycle processes. ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices. NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3. AAMI / ANSI / ISO 10993-1:2009/(R)2013. biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

Clinical Studies: Not applicable. The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

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

Not Found

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

K161525

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

K171891, K163690, K140254, K171233, K171034

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

July 30th, 2018 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Yang ZhaoHui Engineer of Technical Regulation Depart Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan Shenzhen, Guangdong 518057 P.R. CHINA

Re: K180912

Trade/Device Name: TE7/TE5 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: July 4, 2018 Received: July 9, 2018

Dear Yang ZhaoHui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Ballegoo

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

Enclosure

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Indications for Use

510(k) Number (if known)

K180912

Device Name TE7/TE5 Diagnostic Ultrasound System

Indications for Use (Describe)

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid. testes), neonatal and adult cephalic. trans-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

Type of Use (Select one or both, as applicable)	✔ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)	✔ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
✔ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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TE7/TE5 Diagnostic Ultrasound Indications For Use For Use Format

TE7/TE5 Diagnostic Ultrasound System

System:
Transducer:

N/A

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

Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic	N	N	N		N	N	N	Note 1,2,6
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P	Note 1,2,5
	Abdominal	P	P	P	P	P	P	P	Note 1,2,5,6,7,8
	Intra-operative (Specify*	P	P	P		P	P	P	Note 1,2
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,5,6,8
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,6,8
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,5
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,5
	Trans-rectal	P	P	P		P	P	P	Note 1,2,5
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5
	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 1,2,6,8
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1,4,5
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,5,6,8
	Other (Specify***)	P	P	P	P	P	P	P	Note 1,2,5
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.
Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
Note8: eSpacial Navi
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application						Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5
	Adult Cephalic
Fetal Imaging
& Other	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 1,2,5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
	Other (Specify***)
	N=new indication; P=previously cleared by FDA					(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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application				Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2,5
	Abdominal	P	P	P		P	P	P	Note 1,2,5,7
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5
	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 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					(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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
		Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Clinical Application		Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic		Ophthalmic
		Fetal
		Abdominal
		Intra-operative (Specify*
	Fetal Imaging
& Other	Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal
(Conventional)
		Musculo-skeletal
(Superficial)
		Intravascular
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1,4,5
	Peripheral
vessel	Intra-cardiac
		Peripheral vessel
		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.
		Note2: Biopsy Guidance
		Note3: Contrast imaging (Contrast agent for LVO)
		Note4: TDI
		Note5: Color M
	Note6: Smart 3D
		Note7: Contrast imaging (Contrast agent for Liver)
		Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
		Concurrence of CDRH, Office of Device Evaluation(ODE)

4

C11-3s

TE7/TE5 Diagnostic Ultrasound System System:

Transducer: C11-3s

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

5

C5-2s
System:
Transducer: TE7/TE5 Diagnostic Ultrasound System C5-2s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

6

P7-3Ts

TE7/TE5 Diagnostic Ultrasound System System: Transducer: P7-3Ts Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

7

L12-4s
System: TE7/TE5 Diagnostic Ultrasound System Transducer: L12-4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic	N	N	N	N	N	N	N	Note 1,2,6
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,6
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,6
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,6
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,6
	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	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
vessel	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2
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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2
	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic	N	N	N		N	N	N	Note 1,2,6
	Fetal
	Abdominal
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,6
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,6
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,6
	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1,2,5
	Abdominal	P	P	P	P	P	P	P	Note 1,2,5
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,5
Fetal Imaging
& Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,3,4,5
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Clinical Application	Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2,5
	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 1,2,5
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,5
	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
				(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH. Office of Device Evaluation(ODE)
	Clinical Application						Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic		Ophthalmic
		Fetal
		Abdominal	P	P	P	P	P	P	P	Note 1,2
		Intra-operative (Specify*	P	P	P	P	P	P	P	Note 1,2
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric	P	P	P	P	P	P	P	Note 1,2
		Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2
		Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2
Fetal Imaging
& Other		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal
(Conventional)	P	P	P	P	P	P	P	Note 1,2
		Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1,2
		Intravascular
		Cardiac Adult
		Cardiac Pediatric
Cardiac		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral
vessel		Peripheral vessel	P	P	P	P	P	P	P	Note 1,2
		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.
Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
Note8: eSpacial Navi
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application						Mode of Operation
	General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		P	P	P	P	P	P	P	Note 1
	Intra-operative (Specify*)		P	P	P	P	P	P	P	Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P	P	P	P	P	Note 1
	Small Organ (Specify**)		P	P	P	P	P	P	P	Note 1
	Neonatal Cephalic		P	P	P	P	P	P	P	Note 1
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)		P	P	P	P	P	P	P	Note 1
	Musculo-skeletal
(Superficial)		P	P	P	P	P	P	P	Note 1
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel		P	P	P	P	P	P	P	Note 1
vessel	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application							Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,5
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	P	P	P	P	P	P	Note 1, 4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	Clinical Application		Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
Ophthalmic		Ophthalmic	N	N	N	N	N	N	N	Note 1
		Fetal
		Abdominal
		Intra-operative (Specify*
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1
		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	P	Note 1
		Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral
vessel		Peripheral vessel	P	P	P	P	P	P	P	Note 1
		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.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Clinical Application		Mode of Operation
	General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic		Ophthalmic
		Fetal	P	P	P		P	P	P	Note 1,2,5
		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**)
	Fetal Imaging
& Other	Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2,5
		Musculo-skeletal
(Superficial)
		Intravascular
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
	Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
		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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N	N	N	N	N	Note 1,2,5
	Abdominal	P	P	P	P	P	P	P	Note 1,2,5
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,5
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,5
	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
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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.
Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
Note8: eSpacial Navi
(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 Specific (Track 1 & 3)
1 Only)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
Ophthalmic
Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P	Note 1,2,5
	Abdominal
	Intra-operative (Specify*
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,5
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,5
	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.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
Clinical Application	Mode of Operation
General (Track
Specific (Track 1 & 3)
1 Only)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1, 2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1, 2
	Neonatal Cephalic	P	P	P		P	P	P	Note 1, 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1, 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1, 2
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2
	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.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
Note8: eSpacial Navi
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,5
Fetal Imaging &
Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1,5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,4,5
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K163690); 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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
	Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
	Ophthalmic
Ophthalmic	Fetal	P	P	P		P	P	P	Note 1,2,5
	Abdominal	P	P	P		P	P	P	Note 1,2,5,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
Peripheral vessel	Other (Specify***)
N=new indication; P=previously cleared by FDA (K163690); 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.
Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
Note8: eSpacial Navi
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1,2,5
	Abdominal	P	P	P	P	P	P	P	Note 1,2,5,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5
	Small Organ (Specify**)
	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 1,2,5
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,5
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral vessel
Peripheral vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K171233); 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.
	Note2: Biopsy Guidance
	Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
	Note5: Color M
	Note6: Smart 3D
	Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2
	Other (Specify***)
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	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 1,2,8
	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 1,2,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral vessel	P	P	P		P	P	P	Note 1,2,8
Peripheral vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(171233); 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.
Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,8
	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 1,2,8
	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 1,2,8
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2,8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Peripheral vessel
	Other (Specify***)
Peripheral vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,8
	N=new indication; P=previously cleared by FDA(K171233); 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.
	Note2: Biopsy Guidance
Note3: Contrast imaging (Contrast agent for LVO)
Note4: TDI
Note5: Color M
Note6: Smart 3D
Note7: Contrast imaging (Contrast agent for Liver)
	Note8: eSpacial Navi
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

8

L7-3s
System:
Transducer: TE7/TE5 Diagnostic Ultrasound System L7-3s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

9

L14-6s
System:

10

L14-6Ns
System: TE7/TE5 Diagnostic Ultrasound System Transducer: L14-6Ns Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

11

P4-2s

TE7/TE5 Diagnostic Ultrasound System System: Transducer: P4-2s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

12

V11-3Ws

TE7/TE5 Diagnostic Ultrasound System System: Transducer: V11-3Ws Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

13

7LT4s

System:
Transducer: TE7/TE5 Diagnostic Ultrasound System

7LT4s

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

14

L14-5sp

TE7/TE5 Diagnostic Ultrasound System System:

Transducer: L14-5sp

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

15

P10-4s

TE7/TE5 Diagnostic Ultrasound System System: Transducer: P10-4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

16

L20-5s

TE7/TE5 Diagnostic Ultrasound System System:

Transducer: L20-5s

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

17

SC6-1s

TE7/TE5 Diagnostic Ultrasound System

System:
Transducer: SC6-1s

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

18

SP5-1s

TE7/TE5 Diagnostic Ultrasound System System: Transducer: SP5-1s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

19

6CV1s

TE7/TE5 Diagnostic Ultrasound System System:

Transducer: 6CV1s

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

20

7L4s

System: TE7/TE5 Diagnostic Ultrasound System

Transducer: 7L4s

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

21

P7-3s TE7/TE5 Diagnostic Ultrasound System System: Transducer: P7-3s Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

22

C5-1s

TE7/TE5 Diagnostic Ultrasound System System:

C5-1s Transducer:

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

23

C4-1s

TE7/TE5 Diagnostic Ultrasound System System:

C4-1s Transducer:

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

24

L9-3s TE7/TE5 Diagnostic Ultrasound System System: Transducer: L9-3s Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

25

L11-3VNs TE7/TE5 Diagnostic Ultrasound System System: Transducer: L11-3VNs Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

26

L12-3RCs

TE7/TE5 Diagnostic Ultrasound System System:

Transducer: L12-3RC

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

27

L14-5Ws

System:	TE7/TE5 Diagnostic Ultrasound System
Transducer:	L14-5Ws
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | Other
(specify) | |
|---------------------------|---------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|----------|
| General (Track
1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2 | |
| | 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 | |
| | Musculo-skeletal
(Superficial) | P | P | P | | P | P | P | Note 1,2 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Peripheral vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2 |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K171233); 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. | | | | | | | | | |
| | Note2: Biopsy Guidance | | | | | | | | | |
| | Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | |
| | Note4: TDI | | | | | | | | | |
| | Note5: Color M | | | | | | | | | |
| | Note6: Smart 3D | | | | | | | | | |
| | Note7: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note8: eSpacial Navi | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |

28

510(K) SUMMARY

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

1. Submitter:

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

Tel: [phone] Fax: [phone]

Contact Person:

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

March 26, 2018 Date Prepared:

2. Device Name: TE7 Diagnostic Ultrasound System, TE5 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:

B-1

Resp-007-1

29

TE7/TE5 is a 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, LVO, Color M, Smart 3D, TDI 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.

4. Intended Use:

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), Pediatric .small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

5. Summary of Modifications

This submission device is a modification to TE7/TE5 Diagnostic Ultrasound System previously cleared in K161525.

The following is a brief overview of the modifications.

• Newly added transducers: C5-1s, L9-3s, L11-3VNs, C4-1s, L12-3RCs, L14-5Ws, P7-3s
• . New Added Needle-Guided Bracket: NGB-022, NGB-034, NGB-035, NGB-036
• . Newly added Features:
  • eSpacial Navi

Auto EF

Exam mode of Ophthalmic for Liner probes L14-6Ns、L12-4s、L20-5s Exam mode of OB for Phased probes SP5-1s、 P4-2s

. Add the Contrast Imaging(for liver) Function to C5-1s、C4-1s and C5-2s

All of the above modifications and newly added features have been compared with the

30

predicate devices. The results show that these modifications and newly added features are substantially equivalent to the predicate devices.

6. Comparison with Predicate Devices:

TE7/TE5 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate Device | Manufacturer | Model | 510(k) Control
Number |
|----------------------------|--------------|------------|--------------------------|
| 1.Primary predicate device | Mindray | TE7 | K161525 |
| 2. Reference device | Zonare | ZS3 | K171891 |
| 3.Reference device | Mindray | DC-70 | K163690 |
| 4.Reference device | eZono AG | eZono 4000 | K140254 |
| 5.Reference device | Mindray | Resona 7 | K171233 |
| 6.Reference device | Mindray | M9 | K171034 |

TE7/TE5 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.

• . Subject device TE7/TE5 has the same intended uses as the predicated device TE7/TE5 (K161525)
• The materials of probes and Needle-guided brackets of TE7/TE5 are the same to the probe of predicate device.
• . The acoustic power levels of TE7/TE5 are below the limits of FDA, which is the same as the predicated device TE7/TE5 (K161525) and ZS3(K171891).
• . TE7/TE5 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device TE7/TE5 (K161525).

31

7. Non-clinical Tests:

TE7/TE5 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 found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
• . IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
• . IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
• AAMI / ANSI / IEC 62304:2006, medical device software software life cycle processes.
• . ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
• NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
• AAMI / ANSI / ISO 10993-1:2009/(R)2013. biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.

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, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

B-4

Resp-007-4

32

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 TE7/TE5 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.