Predicate Devices

Reference Devices

Not Found.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The lack of information on training/test sets and key metrics further supports this conclusion.

Therapeutic

No
The device is described as a "general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation" and for "clinical diagnostic imaging applications," indicating its purpose is diagnostic, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" states it's "intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ..." and the "Device Description" explicitly calls it an "integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications." It also mentions it's a "color diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Digital Color Doppler Ultrasound System" consisting of a "mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes." These are hardware components, not solely software.

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 description clearly states that this device is a "Digital Color Doppler Ultrasound System." It transmits ultrasonic energy into the patient's body and processes the received echoes to generate images of internal structures and fluid flow. This is an in vivo (within the living body) imaging technique, not an in vitro test.
Intended Use: The intended use lists various anatomical sites and applications for imaging within the body. None of these involve testing samples taken from the body.

Therefore, this ultrasound system is a medical imaging device used for diagnostic purposes within the patient's body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

Additional Intended Use details from page 3 and pages 4-40 for the system and various transducers:
Diagnostic ultrasound imaging or fluid flow analysis of the human body for the following clinical applications: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative Neuro, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph.(non-Card), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Ob/GYN, Urology, Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph.(Cardiac), Intra-cardiac, Peripheral vessel, Cerebral vascular.

Mode of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler. Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD. Other Specify includes: Tissue Harmonic Imaging, TDI, 3D, 4D, Elastography.

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

IYN, IYO, ITX

Device Description

This SonoScape S60 series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 25.0 MHz. This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

Mentions image processing

Yes, "implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body."

Mentions AI, DNN, or ML

Not Found.

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

Indicated Patient Age Range

Neonatal, Pediatric, Adult. (Inferred from Neonatal Cephalic, Pediatric, Adult Cephalic classifications)

Intended User / Care Setting

Qualified physician. Care setting not specified but inferred to be medical clinics or hospitals based on the type of device.

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)

The S60 Series Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. Laboratory tests (including Phantom tests) were conducted to verify that the S60 system met all design specifications and the S60 system conformed to applicable medical device standards.

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.

SonoScape S45 Digital Color Doppler Ultrasound System K160283

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

Not Found.

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

Not Found.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

September 21, 2017

SONOSCAPE MEDICAL CORP. % Ms. Toki Wu Regulatory Affairs Manager 4/f, 5/f, 8/f, 9/f & 10/f Yizhe Building, Yuquan Road, Nanshan Shenzhen 518051, GuangDong CHINA

Re: K172082

Trade/Device Name: S60 Series Digital Color Doppler 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, 2017 Received: July 17, 2017

Dear Ms. Wu:

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

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

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

1

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

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

Sincerely yours,

Michael D. O'Hara For

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K172082

Device Name

S60 Series Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology,

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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3

SonoScape S60 Exp/S60/S60 Pro/S60 VO/S60 Maso/S59 System: Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging System

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
Fetal
Imaging&
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic	P	P	P		P	P	Note 1	Notes 2,4
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes
2,4,5,6,7
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4,5
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4,5
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4,5
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Cerebral vascular			P

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

4

Transducer: C322 Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	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
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

5

Transducer: 3C-A Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	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
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 3D

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

6

Transducer: C1-6 Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	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
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

7

Transducer: C613 Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Fetal
Imaging&
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

8

Transducer: 8P1 Phased Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

9

Transducer: 4P-A Phased Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Fetal
Imaging&
Other	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3,4
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

10

Transducer: S1-5 Phased Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Fetal
Imaging&
Other	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3,4
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

11

Transducer: 7P-A Phased Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Fetal
Imaging&
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

12

Transducer: 1012 Linear Array

Diagnostic Ultrasound Transducer

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

| Clinical Application | Specific
(TRACKS 1 & 3) | B | M | PWD Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify |
|------------------------------|--------------- | General
(TRACK 1
ONLY) | 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-skelet (Conventional) | P | P | P | | P | | Musculo-skelet (Superficial) | | | | | | | Intravascular | | Other (Ob/GYN) | | Other (Urology) | | Cardiac Adult | | Cardiac Pediatric | | Intravascular(Cardiac) | Cardiac | Trans-esoph.(Cardiac) | | Intra-cardiac | | Other (specify) | | Peripheral vessel | | Cerebral vascular | Peripheral
Vessel | | CWD | Color
---------------------|---|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| P | P | P | | P | P | Note 1 | Notes 2,4,6 |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
al
| P | Note 1 | Notes 2,4 |
al
| | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| P | P | P | | P | P | Note 1 | Notes 2,4 |
| | | | | | | | |
| | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 3D

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

13

Transducer: 9L-A Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	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	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

14

Transducer: 12L-A Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,7
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

15

Transducer: VL12-5 Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes
2,4,5,6
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
Vessel	Cerebral vascular

P = previously cleared by FDA; N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

16

Transducer: 6V3 Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	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	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

17

Transducer: 6V7 Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
Other	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes

Note 7: Elastography

Note 5: 4D

18

Transducer: BCC9-5 Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	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	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 3D

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

19

Transducer: BCL10-5 Biplane Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	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	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

20

Transducer: VE9-5 Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
Fetal
Imaging&
Other	Trans-rectal	P	P	P		P	P	Note 1	Notes
2,4,5
	Trans-vaginal	P	P	P		P	P	Note 1	Notes
2,4,5
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes
2,4,5
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

21

Transducer: MPTEE Phased Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)	P	P	P	P	P	P	Note 1	Notes
2,3,4
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

22

Transducer: MPTEE mini Phased Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	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
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)	P	P	P	P	P	P	Note 1	Notes
2,3,4
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

23

Transducer: LAP7 Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic	P	P	P		P	P	Note 1	Notes 2,4
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Note 7: Elastography

Note 5: 4D

24

Transducer: PWD2.0

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	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
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular			P

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 3D

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

25

Transducer: C1-6A Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	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
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

26

Transducer: C2-9 Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
Fetal
Imaging&
Other	Intra-operative Specify
	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
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

27

Transducer: 12L-B Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,7
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	N	N	N		N	N	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
Vessel	Cerebral vascular

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 4: 3D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

28

Transducer: 13L-A Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,7
	Neonatal Cephalic
Fetal
Imaging&
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	N	N	N		N	N	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

Note 4: 3D

29

Transducer: 18L-A Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N	N	N	N	Note 1	Notes 2,4,6
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N	N	N	N	Note 1	Notes 2,4
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

Note 4: 3D

30

Transducer: VC2-9A Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	Note 1	Notes 2,4,5
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4,5
	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
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4,5
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

31

Transducer: VC2-9 Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	Note 1	Notes 2,4,5
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4,5
	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
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4,5
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

32

Transducer: C3-10V Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal	N	N	N	N	N	N	Note 1	Notes 2,4
Other	Trans-vaginal	N	N	N	N	N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	N	N	N	N	N	N	Note 1	Notes 2,4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

33

Transducer: 6V3A Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	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	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

34

Transducer: 12C-ER Micro-curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	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	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	N	N	N		N	N	Note 1	Notes 2,4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

35

Transducer: 12LT-A Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,6
	Neonatal Cephalic
Fetal
Imaging&
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

36

Transducer: 12LI-A Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,6
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

37

Transducer: 6CI-A Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	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
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

38

Transducer: 6CT-A Curved Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
	Other (Urology)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

39

Transducer: ML3-18 Linear Array

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

40

Transducer: CWD5.0

Diagnostic Ultrasound Transducer

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
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult				N
Cardiac	Cardiac Pediatric				N
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;

B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

41

510(k) Summary

1. Submitter [21 CFR807.92 (a) (1)]

Submitter:	SONOSCAPE MEDICAL CORP.
Address:	4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road,
Nanshan, Shenzhen 518051, Guangdong, China
Contact Person:	Toki Wu
Tel:	+86 755 26722890
Fax:	+86 755 26722850
Email:	ra@sonoscape.net
Date Prepared	July 4, 2017

2. Device [21 CFR807.92 (a) (2)]

Trade Name:	S60 Series Digital Color Doppler Ultrasound System
Common Name:	Diagnostic Ultrasound System and Transducers

Classification Regulatory:

	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

Classification Panel: Radiology Device Class: ll

3. Predicate Device(s) [21 CFR 807.92(a) (3)]

The identified predicate device within this submission is as follows: SonoScape S45 Digital Color Doppler Ultrasound System K160283

4. Device Description [21 CFR 807.92(a) (4)]

This SonoScape S60 series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of

42

anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 25.0 MHz. This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

5. Intended Use [21 CFR 807.92(a) (5)]

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

6. Comparison with the Predicate device [21 CFR 807.92(a) (6)]

S60 Series Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:

SonoScape S45 Digital Color Doppler Ultrasound System K160283

Intended Use Comparison:

Compared with the predicate device SonoScape S45 (K160283), the Subject Device S60 Series has the same intended use.

Technical Characteristics Comparison:

The basic and key technical features of the Subject Device S60 Series are the same as the predicate device SonoScape S45 (K160283), including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition.

Probes Comparison:

Subject device S60 Series has the similar probes as the predicate device SonoScape S45 (K160283).

Table 1 Probes Comparison

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| Comparison
Items | Subject device
SonoScape S60 Exp/S60/S60
Pro/S60 VO/S60 Maso/S59 | Predicate Device
SonoScape S45 series | Remark |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Probes | C322 Micro-curved Array
3C-A Curved Array
C1-6 Curved Array
C1-6A Curved Array
6CT-A Curved Array
6CI-A Curved Array
C2-9 Curved Array | C322 Micro-curved Array
3C-A Curved Array
C1-6 Curved Array
C1-6A Curved Array
6CT-A Curved Array
6CI-A Curved Array
C2-9 Curved Array | SE
Analysis1 |
| | C613 Micro-curved Array
VC2-9A Curved Array
VC2-9 Curved Array | VC6-2 Curved Array
C613 Micro-curved Array
VC2-9A Curved Array
VC2-9 Curved Array | |
| | 8P1 Phased Array
4P-A Phased Array
S1-5 Phased Array
7P-A Phased Array | 8P1 Phased Array
4P-A Phased Array
S1-5 Phased Array
7P-A Phased Array | |
| | 10I2 Linear Array
9L-A Linear Array
12L-A Linear Array
VL12-5 Linear Array
12L-B Linear Array
13L-A Linear Array
18L-A Linear Array
ML3-18 Linear Array
12LT-A Linear Array
12LI-A Linear Array | L742 Linear Array
10I2 Linear Array
9L-A Linear Array
12L-A Linear Array
VL12-5 Linear Array
12L-B Linear Array
13L-A Linear Array
18L-A Linear Array
10L-I Linear Array
ML3-18 Linear Array
12LT-A Linear Array
12LI-A Linear Array | SE
Analysis2 |
| | 6V3 Micro-curved Array
6V3A Micro-curved Array
6V7 Micro-curved Array
BCC9-5 Micro-curved Array
BCL10-5 Biplane (Micro-curved

Linear Array)
VE9-5 Micro-curved Array
12C-ER Micro-curved Array
C3-10V Micro-curved Array | 6V1 Micro-curved Array
6V3 Micro-curved Array
6V3A Micro-curved Array
6V7 Micro-curved Array
EC9-5 Micro-curved Array
BCC9-5 Micro-curved Array
BCL10-5 Biplane (Micro-curved
Linear Array)
VE9-5 Micro-curved Array
12C-ER Micro-curved Array
C3-10V Micro-curved Array
VE3-10 Micro-curved Array | SE
Analysis1 |
| PWD2.0 Doppler | PWD2.0 Doppler | SE | |
| CWD5.0 CW | CWD5.0 CW | | |
| MPTEE Phased Array | CWD8.0 CW | Analysis3 | |
| MPTEE mini Phased Array | CWD2.0 CW | | |
| LAP7 Linear Array | MPTEE Phased Array | | |
| | MPTEE mini Phased Array | | |
| | LAP7 Linear Array | | |

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SE Analysis 1 :

Compared with the predicate device, there are nine new Curved Array probes as followed: (C1-6A, C2-9), which is similar with the probe (C1-6) cleared with predicate device SonoScape S45 (K160283). The new probe (6CT-A, 6CI-A) which is similar with the probe (C322) cleared with predicate device SonoScape S45 (K160283). The new probe (VC2-9A, VC2-9) which is similar with the probe (VC6-2) cleared with predicate device SonoScape S45 (K160283). The new probe (12C-ER, C3-10V) which is similar with the probe (6V3) cleared with predicate device SonoScape S45 (K160283). The new probe (6V3A) which is similar with the probe (6V1A) cleared with predicate device SonoScape S45 (K160283).

SE Analysis 2: Compared with the predicate device, there are six new Linear Array probes as followed:

The new probe (12L-B, 13L-A, 18L-A) which is similar with the probe (L742) cleared with predicate device SonoScape S45 (K160283). The new probe (12LT-A, 12LI-A) which is similar with the probe (10l2) cleared with predicate device SonoScape S45 (K160283). The new probe (ML3-18) which is similar with the probe (L752) cleared with predicate device SonoScape S45 (K160283).

SE Analysis 3: Compared with the predicate device, there is one new CW probes as followed:

The new probe (CWD5.0) which is similar with the probe (CWD2.0) cleared with predicate device SonoScape S45 (K160283). The clinical application is the same, the performance or frequency is similar, and the difference of these doesn't affect the safety, effectiveness and clinical use.

7. Non-Clinical Tests [21 CFR 807.92(b) (1)]

The S60 Series Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

Laboratory tests (including Phantom tests) were conducted to verify that the S60 system

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met all design specifications and the S60 system conformed to applicable medical device standards.

The S60 Series system has been designed and manufactured to meet the following standards:

IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance [08/20/2012];

IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests [03/30/2007];

IEC 60601-2-37:2007, Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment [08/09/2007];

ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity [06/01/2009];

ISO 10993-10:2010, Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization [08/01/2010];

AIUM/NEMA UD 2:2004 (R2009), Acoustic output measurement standard for diagnostic ultrasound equipment [08/21/2009]; and

AIUM/NEMA UD 3:2004 (R2009). Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment [08/13/2010].

8. Clinical Test [21 CFR 807.92(b) (2)]

No clinical testing was required.

9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]

In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SONOSCAPE MEDICAL CORP. concludes that S60 Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.