Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound technology and signal processing techniques, with no mention of AI or ML.

Therapeutic

No
The device is described as an "ultrasonic instrument intended for use by a qualified physician for evaluation" and "producing high detail resolution intended for clinical diagnostic imaging applications," indicating its purpose is diagnosis, not therapy.

Diagnostic

Yes

The device description explicitly states it is "intended for clinical diagnostic imaging applications" and it "processes the signals...and images the organs...then analyzes the distance and the status of organs."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" that utilizes probes (transducers) to transmit and receive acoustic signals, and includes hardware components like a keyboard control panel, power supply module, and color LCD monitor. This is a hardware-based ultrasound system, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this device is an ultrasound system that transmits ultrasonic energy into the patient body and processes the echo signals to create images of organs and blood flow. This is an in vivo (within the living body) diagnostic method, not in vitro.
Intended Use: The intended uses listed are all related to imaging internal structures of the body directly, not analyzing samples taken from the body.

Therefore, this Digital Color Doppler Ultrasound System is a diagnostic imaging device, but it does not fit the definition of 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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

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), OB/Gyn and Urology.

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

IYN, IYO, ITX

Device Description

This SonoScape X5 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 X5 Series system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and auto-correlation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.

This system (X5 Series Digital Color Doppler Ultrasound System) are additional models (X5 Exp, X5 Pro, X6, X6 Exp, X6 Pro), additional transducers (C1-6, 12L-B, 9L-A, 18L-A, 13L-A, L746, 10L-I, 1012, 6V7, 6V3, 6V3A, C361, VC6-2, C542, C322, 12LT-A, 12LI-A, 6CT-A, 6CI-A, BCC9-5, S1-5, 2P1, CWD5.0, CWD2.0, MPTEE and MPTEE min probes), additional functions (Elastography, Contrast imaging) and updated intended use (Trans-esoph.(Cardiac)) to legally marketed SonoScape X5 (K160258).

Mentions image processing

Yes

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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), OB/Gyn, Urology, Cerebral Vascular.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Qualified physician

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 testing to assure compliance with electrical, mechanical, thermal and electromagnetic compatibility safety, acoustic output and biocompatibility were performed and have been found to conform to applicable standards. The X5 Series system has been designed and manufactured to meet the following standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-2-37:2007, ISO 10993-5:2009, ISO 10993-10:2010, AIUM/NEMA UD 2:2004 (R2009), and AIUM/NEMA UD 3:2004 (R2009). Laboratory tests (including Phantom tests) were conducted to verify that the X5 Series system met all design specifications and the X5 Series system conformed to applicable medical device standards. The tests included electrical safety testing, EMC testing, acoustic testing, and software verification and validation, all of which passed. No clinical testing was required.

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

Not Found

Predicate Device(s)

K173058

Reference Device(s)

K160258, K160807

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 29, 2019

Sonoscape Medical Corp. 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: K182648

Trade/Device Name: X5 Series Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN Dated: December 14, 2018 Received: December 27, 2018

Dear Toki Wu:

We have reviewed vour 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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hol. 2. mils

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K182648

Device Name

X5 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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), 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.

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

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

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FORM FDA 3881 (8/14)

3

X5 Series Digital Color Doppler Ultrasound System System: (including: X5 Exp, X5, X5 Pro, X6 Exp, X6, X6 Pro) 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
	Abdominal	P	P	P		P	P	Note 1	Notes 2,8
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,6,7
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
Fetal	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
Imaging&	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
Other	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2
	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)	P	P	P	P	P	P	Note 1	Notes 2,3
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P	N	P	P	Note 1	Notes 2
Vessel	Cerebral vascular				N

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

Note 7: Elastography

4

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
		Abdominal	P	P	P		P	P	Note 1
	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
	Other (Urology)
Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

5

Transducer: C613 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
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
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
	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: BM; 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

Note 7: Elastography

6

Transducer: 3P-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
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
Fetal	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
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	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	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

Note 7: Elastography

7

Transducer: 7P-B 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
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
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	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2
	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: BM; 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

Note 7: Elastography

8

Transducer: L741 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 2,6,7
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	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
Vessel	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

9

Transducer: 6V1 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
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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
	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 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

Note 7: Elastography

10

Transducer: EC9-5 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
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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
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: BM; 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

Note 7: Elastography

11

Transducer: C322 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	P	P	P		P	P	Note 1	Notes 2
	Abdominal	P	P	P		P	P	Note 1	Notes 2,8
	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
	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; N = new indication; 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

Note 7: Elastography

12

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
	Abdominal	P	P	P		P	P	Note 1	Notes 2,8
	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

13

Transducer: VC6-2 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
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	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)	P	P	P		P	P	Note 1	Notes 2
	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; N = new indication; 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

Note 7: Elastography

14

Transducer: 2P1 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
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	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	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(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/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

Note 7: Elastography

15

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
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
Fetal	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
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	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	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: BM; 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

Note 7: Elastography

16

Transducer: L746 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
Fetal
Imaging&
Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
Cardiac	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

17

Transducer: 1012 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)	P	P	P		P	P	Note 1	Notes 2,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2
	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	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

18

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 2,6,7
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

19

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)	P	P	P		P	P	Note 1	Notes 2,6,7
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	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/THl; M/Color Doppler; B/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

Note 7: Elastography

20

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	Adult Cephalic
Imaging&	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
Other	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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
	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 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

Note 7: Elastography

21

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
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
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
	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

Note 7: Elastography

22

Transducer: BCC9-5 Biplane (curved+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
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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
	Cardiac Adult
	Cardiac Pediatric
Cardiac	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: BM; 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

Note 7: Elastography

23

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
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
	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: BM; 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

Note 7: Elastography

24

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	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
	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: BM; 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

Note 7: Elastography

25

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
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

26

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)	P	P	P		P	P	Note 1	Notes 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	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	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
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

27

Transducer: 10L-I 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 2,6
	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
	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	P	P	P		P	P	Note 1	Notes 2
	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/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

Note 7: Elastography

28

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	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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

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

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

Note 7: Elastography

29

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)	P	P	P		P	P	Note 1	Notes 2,6
	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
	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
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

Note 7: Elastography

30

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)	P	P	P		P	P	Note 1	Notes 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	Note 1	Notes 2
	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	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

31

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
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
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	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
	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: BM; 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

Note 7: Elastography

32

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	P	P	P		P	P	Note 1	Notes 2
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	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/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

Note 7: Elastography

33

Transducer: CWD2.0

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				P
	Cardiac Pediatric				P
	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

Note 7: Elastography

34

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
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)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel				N
	Cerebral vascular				N

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

Note 1: Other Combined includes: BM; 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

Note 7: Elastography

35

Transducer: C542 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
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
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
	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: BM; 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

Note 7: Elastography

36

Transducer: C361 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
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular(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/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 4: 3D

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

Note 7: Elastography

Note 3: TDI

37

510(k) Summary K182648

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	January 22 2019

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

Trade Name:	X5 Series Digital Color Doppler Ultrasound System
Model:	X5/X5 Exp/X5 Pro/X6/X6 Exp/X6 Pro
Common Name:	Diagnostic Ultrasound System and Transducers

Classification Regulatory:

		CFR Number	Product Code
	Ultrasonic Pulsed Doppler Imaging System
(Primary)	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:	II

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

The identified predicate device within this submission is as follows:

Type	Manufacturer	Device	510 (K) Number
Main predicate
device	Sonoscape
Medical Corp.	P10 Series Digital Color
Doppler Ultrasound System	K173058
Reference Device	Sonoscape
Medical Corp.	X5 Digital Color Doppler
Ultrasound System	K160258
Reference Device	Philips
Ultrasound, Inc.	EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System	K160807

38

4. Device Description [21 CFR 807.92(a) (4)1

This SonoScape X5 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 X5 Series system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and auto-correlation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.

This system (X5 Series Digital Color Doppler Ultrasound System) are additional models (X5 Exp, X5 Pro, X6, X6 Exp, X6 Pro), additional transducers (C1-6, 12L-B, 9L-A, 18L-A, 13L-A, L746, 10L-I, 1012, 6V7, 6V3, 6V3A, C361, VC6-2, C542, C322, 12LT-A, 12LI-A, 6CT-A, 6CI-A, BCC9-5, S1-5, 2P1, CWD5.0, CWD2.0, MPTEE and MPTEE min probes), additional functions (Elastography, Contrast imaging) and updated intended use (Trans-esoph.(Cardiac)) to legally marketed SonoScape X5 (K160258).

Note: X5 Exp, X5, X5 Pro, X6 Exp, X6, X6 Pro models are considered as a serial products as they are the same except partial functions, including the same design, hardware, software, mechanic construction, power supply board, main board, specification and etc. The differences among them can be seen as the following table.

Model	Configuration Description
X5 Exp	With full functions and configuration
X5	Does not support the velocity measurement compared with X5 Exp
X5 Pro	Does not support the slope ratio measurement compared with X5 Exp

Table 1 Comparison table

39

X6 Exp	Does not support the time ratio measurement compared with X5 Exp
X6	Does not support the time ratio, slope ratio measurement compared with X5 Exp
X6 Pro	Does not support the time ratio, velocity measurement compared with X5 Exp
Note: The slope ratio, time ratio, velocity and velocity ratio measurement items mentioned
above refer to those of the M-mode basic measurements for Urology.

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), OB/Gyn and Urology.

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

X5 Series Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:

Type	Manufacturer	Device	510 (K) Number
Main
device	Sonoscape
Medical Corp.	P10 Series Digital Color
Doppler Ultrasound System	K173058
Reference Device	Sonoscape
Medical Corp.	X5 Digital Color Doppler
Ultrasound System	K160258
Reference Device	Philips
Ultrasound, Inc.	EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System	K160807

X5 Series Digital Color Doppler Ultrasound System has the same intended uses, complies with the same regulation and safety standards, has the consistent acoustic output levels, has similar probes and has the same technical characteristics as the predicate device legally marketed P10 Series (K173058) , X5 (K160258) and EPIQ 5/EPIQ (K160807).

Intended Use Comparison:

Compared with the predicate device P10 Series (K173058), the Subject Device X5 Series has the same intended use.

Table 2 Intended use Comparison

Subject Device	Predicate Device	Remark
----------------	------------------	--------

40

| SonoScape X5/X5 Exp/X5 Pro/X6
/X6Exp/X6 Pro | Legally marketed
SonoScape P10 Exp, P10, P10Pro,
P11, M10, P9 (K173058) | Same | | |
|------------------------------------------------|-------------------------------------------------------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | 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),
OB/Gyn and Urology. | The device 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. |

Technical Characteristics Comparison:

Compared with the predicate device P10 Series (K173058), the Subject Device X5 Series has the similar technical characteristics, including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition. And the differences will not raise new risk and different questions of safety and effectiveness.

Probes Comparison:

Subject device X5 Series has the similar probes as the predicate device SonoScape P10 Series (K173058).

Subject device	Predicate Device
SonoScape X5/X5 Exp/X5
Pro/X6/X6 Exp/X6 Pro	SonoScape P10 Exp, P10,
P10Pro, P11, M10, P9 (K173058)	Remark
C322 Micro-curved Array	C322 Micro-curved Array
C361 Micro-curved Array	C351 Micro-curved Array
3C-A Curved Array	C361 Micro-curved Array

C1-6 Curved Array	3C-A Curved Array
6CT-A Curved Array	C1-6 Curved Array
6CI-A Curved Array	6CT-A Curved Array
	6CI-A Curved Array
VC6-2 Curved Array	VC6-2 Curved Array
C613 curved Array	C613 curved Array
C542 curved Array	C542 curved Array
2P1 Phased Array	2P1 Phased Array
S1-5 Phased Array	S1-5 Phased Array
7P-B Phased Array	7P-B Phased Array
3P-A Phased Array	3P-A Phased Array
L741 Linear Array	L742 Linear Array
L746 Linear Array	L741 Linear Array
10I2 Linear Array	L746 Linear Array
9L-A Linear Array	10I2 Linear Array
12L-B Linear Array	9L-A Linear Array
13L-A Linear Array	12L-B Linear Array
18L-A Linear Array	13L-A Linear Array
10L-I Linear Array	18L-A Linear Array
12LT-A Linear Array	10L-I Linear Array
12LI-A Linear Array	12LT-A Linear Array
	12LI-A Linear Array
6V1 Micro-curved Array	6V1 Micro-curved Array
6V3 Micro-curved Array	6V3 Micro-curved Array
6V3A Micro-curved Array	6V3A Micro-curved Array
6V7 Micro-curved Array	6V7 Micro-curved Array
EC9-5 Micro-curved Array	EC9-5 Micro-curved Array
BCC9-5 Micro-curved Array	BCC9-5 Micro-curved Array
	BCL10-5 Biplane (Micro-curved +
Linear Array)
CWD2.0 CW	PWD2.0 Doppler
CWD5.0 CW	CWD2.0 CW	SE
MPTEE Phased Array	MPTEE Phased Array	Analysis 1
MPTEE mini Phased Array	MPTEE mini Phased Array
	LAP7 Linear Array

Table 3 a) Probes Comparison

41

42

SE Analysis 1:

Compared with the predicate device, there is new CW probes (CWD5.0), which is similar with the probe D5cwc cleared with predicate device EPIQ 5/EPIQ 7 Diagnostic Ultrasound System (K160807). 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.

The engineering drawings of the additional transducers/probes (CWD5.0), and the further comparison are provided as follows.

| Compariso
n Items | Subject Device
SonoScape X5/X5 Exp/X5
Pro/X6 /X6Exp/X6 Pro | Predicate Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K160807) | Remark |
|------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe1 | CWD5.0 | D5cwc | / |
| Photo | Image: Probe | Image: Probe | / |
| Probe Type | Doppler | Doppler | Same |
| Frequency | 5.0MHz | 5.0MHz | Same |
| Indication
for use | Peripheral vessel, Cerebral
Vascular | Peripheral vessel,
Cerebral
Vascular | Same |
| Operation
Mode | CW | CW | Same |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA:
720mW/cm2 maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Comparis
on Items | Subject Device
SonoScape X5/X5 Exp/X5
Pro/X6 /X6Exp/X6 Pro | Predicate Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K160807) | Remark |
| Probe2 | C322 | C6-2 | / |
| Photo | Image: SonoScape X5/X5 Exp/X5 Pro/X6 /X6Exp/X6 Pro Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe | / |
| Probe
Type | Micro-curved Array | Curved Array | Same |
| Frequency | 2.0-7.0MHz | 2.0-6.0MHz | SE
Analysis 2 |
| Indication
for use | Fetal,
Abdominal,
Other(Ob/GYN) | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
| Operation
Mode | B,THI,M,CFM,PDI,PW | B,THI,M,CFM,PDI,PW | Same |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging,
THI,
Contrast Imaging | Compound Imaging,
CPA,
harmonic Imaging,
Contrast
Imaging,
3D/4D
Imaging,
XRES, Elastography | SE
Analysis 3 |
| Comparis
on Items | Subject Device
SonoScape X5/X5 Exp/X5
Pro/X6 /X6Exp/X6 Pro | Predicate Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K160807) | Remark |
| Probe3 | 3C-A | C6-2 | / |
| Photo | Image: SonoScape X5/X5 Exp/X5 Pro/X6 /X6Exp/X6 Pro probe | Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System probe | / |
| Probe
Type | Curved Array | Curved Array | Same |
| Frequency | 1.0-7.0MHz | 2.0-6.0MHz | SE
Analysis 2 |
| Indication
for use | Fetal,
Abdominal,
Other(Ob/GYN) | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
| Operation
Mode | B,THI,M,CFM,PDI,PW | B,THI,M,CFM,PDI,PW | Same |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging,
THI,
Contrast Imaging | Compound Imaging, CPA,
harmonic Imaging,
Contrast
Imaging,
3D/4D
Imaging,
XRES, Elastography | SE
Analysis 3 |

Table 3 b) Further Comparison for CWD5.0 Probes

Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

Functional Comparison of probes

Compared with the predicate device (K173058), there is new function of contrast

43

imaging in probes (C322, 3C-A and C1-6), which is similar with the probe (C6-2 and C5-1) cleared with predicate device EPIQ 5/EPIQ 7 Diagnostic Ultrasound System (K160807). 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.

The engineering drawings of the new function transducers(probes) (C322, 3C-A, C1-6), and the further comparison are provided as follows.

Table 3 c) Further Comparison for C322 Probes

44

Table 3 d) Further Comparison for 3C-A Probes

Table 3 e) Further Comparison for C1-6 Probes

| Comparis
on Items | Subject Device
SonoScape X5/X5 Exp/X5
Pro/X6 /X6Exp/X6 Pro | Predicate Device | Remark |
|----------------------|------------------------------------------------------------------|-------------------------------------------------------------------|--------|
| | | Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System | |

45

		(K160807)
Probe4	C1-6	C5-1	/
Photo	Image: C1-6 probe	Image: C5-1 probe	/
Probe
Type	Micro-curved Array	Curved Array	Same
Frequency	1.0-8.0MHz	1.0-5.0MHz	SE
Analysis 2
Indication
for use	Fetal, Abdominal,
Other(Ob/GYN)	General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications	Same
Operation
Mode	B,THI,M,CFM,PDI,PW	B,THI,M,CFM,PDI,PW	Same
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, THI,
Contrast Imaging	Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, PercuNav	SE
Analysis 3

SE Analysis 2:

Although the frequency is different, the parameters of the subject device are included in the predicated device, and no new risk is raised.

SE Analysis 3:

Although the functions is different, the functions of the subject device are included in the predicated device, and no new risk is raised.

Moreover, compared with predicate device, the subject device (X5 Series) complies with the same regulation and safety standards and has the consistent acoustic output levels.

Summary of the comparison

46

Compared with the the predicate device legally marketed SonoScape X5 (K160258), the additional transducers, additional functions and updated intended use of the subjective device (X5 Series Digital Color Doppler Ultrasound System) are all analyzed with the predicate device P10 Series (K173058) and EPIQ 5/EPIQ (K160807). The comparison showed that they can be considered Substantially Equivalent in safety and effectiveness. Therefore, there is no new risk raised, and the SE is not affected.

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

Non-clinical testing to assure compliance with electrical, mechanical, thermal and electromagnetic compatibility safety, acoustic output and biocompatibility were performed and have been found to conform to applicable standards. The X5 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].

The new added probes and software feature are also verified through system tests and did not raise any concerns regarding safety or effectiveness. The relevant summarized information are as followed:

| Performance test | Testing protocols and
fail/acceptance criteria | Testing results |
|---------------------------|---------------------------------------------------|-----------------|
| Electrical safety testing | IEC 60601-1:2005+A1:2012 | Passed |

47

EMC testing	IEC 60601-1-2:2007	Passed
Acoustic testing	IEC 60601-2-37:2007
AIUM/NEMA UD 2:2004 (R2009)	Passed
Software Verification and
Validation	IEC 62304:2006 +A 1:2015	Passed

Laboratory tests (including Phantom tests) were conducted to verify that the X5 Series system met all design specifications and the X5 Series system conformed to applicable medical device standards.

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 X5 Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1550 Ultrasonic pulsed doppler imaging system.

Indications for Use

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510(k) Summary K182648

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

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

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

4. Device Description [21 CFR 807.92(a) (4)1

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

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

Intended Use Comparison:

Table 2 Intended use Comparison

Technical Characteristics Comparison:

Probes Comparison:

Table 3 a) Probes Comparison

SE Analysis 1:

Table 3 b) Further Comparison for CWD5.0 Probes

Functional Comparison of probes

Table 3 c) Further Comparison for C322 Probes

Table 3 d) Further Comparison for 3C-A Probes

Table 3 e) Further Comparison for C1-6 Probes

SE Analysis 2:

SE Analysis 3:

Summary of the comparison

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

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

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

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