The SonoScape S9 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Description

The SonoScape S9 Portable 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

AI/ML Overview

The provided text describes a 510(k) summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on a clinical performance study with AI.

Therefore, many of the requested details about acceptance criteria driven by AI performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies, are not explicitly mentioned in this type of submission.

However, I can extract information related to the device's technical specifications and the type of non-clinical testing performed to establish safety and effectiveness for substantial equivalence.

Here's a breakdown of what can and cannot be answered based on the provided document:

What can be answered (related to substantial equivalence and non-clinical testing):

Acceptance Criteria (Indirect): The acceptance criteria are implicitly conformance to recognized safety and performance standards for diagnostic ultrasound equipment, and having technological characteristics similar to the predicate device, demonstrating equivalent capability. The "reported device performance" is the confirmation that these standards were met.
Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for AI. The testing described is laboratory-based non-clinical testing for standards compliance.
Data Provenance: Not applicable, as no clinical test set data from patients is described. The testing is laboratory (acoustic output, electrical, thermal, mechanical safety, biocompatibility).
Number of Experts for Ground Truth & Qualifications: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: No. This is not a study involving human readers and AI assistance.
Standalone (algorithm only) Performance: No, as there isn't an AI algorithm described that would operate in a standalone manner. The device is a diagnostic ultrasound system.
Type of Ground Truth Used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, not clinical diagnostic accuracy.
Sample Size for Training Set: Not applicable. This device does not inherently involve a "training set" in the context of an AI/ML algorithm.
How Ground Truth for Training Set was Established: Not applicable.

Table of Acceptance Criteria and Reported Device Performance (based on regulatory compliance):

Acceptance Criteria Category	Specific Criteria (Implicitly Required for Equivalence)	Reported Device Performance (Summary)
Safety	Conformance to general medical electrical equipment safety standards (IEC 60601-1, IEC 60601-1-2), specific ultrasound equipment safety standards (IEC 60601-2-37), biocompatibility standards (ISO 10993-5, ISO 10993-10), and acoustic output standards (NEMA UD 2, NEMA UD3). This includes thermal, mechanical, and electrical safety.	"The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility." "Acoustic output is measured and calculated according to 'Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment'." The specific standards listed (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, NEMA UD 2, NEMA UD3) were confirmed as met.
Performance/Effectiveness	Able to acquire ultrasound data and display images in specified modes (B-Mode, M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, 3D/4D), and for the intended clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal, Cardiac, OB/Gyn, Urology), demonstrating functionality substantially equivalent to the predicate.	"The SonoScape S9 Portable 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." "Its basic function is to acquire ultrasound data and display the image in B-Mode... M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D." Performance and compliance testing confirmed the device met all design specifications and was substantially equivalent to the predicate, supporting its intended use.
Technological Characteristics	The device's fundamental technology (digital architecture, dynamic receive focusing, exam-dependent settings, transducer compatibility and performance across specified frequency ranges and clinical uses) should be comparable to the predicate device.	The S9 "incorporates the same fundamental technology as the predicate device." "The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system." A detailed table of transducers with their types, frequency ranges, and intended uses is provided, demonstrating their claimed capabilities.

Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical laboratory tests designed to demonstrate compliance with recognized consensus standards and to show that the S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to a previously cleared predicate device (SonoScape Company Limited, Diagnostic Ultrasound System, Model S6, K112602).

Nature of the Study: This was a non-clinical validation focused on safety, electromagnetic compatibility, acoustic output, and biocompatibility, rather than a clinical performance study involving patient data and diagnostic accuracy.
Acceptance Criteria for the Study: The implicit acceptance criteria were successfully passing all relevant tests defined by the listed international and national standards (IEC, ISO, NEMA) and demonstrating that the device's technical specifications and performance characteristics align closely enough with the predicate device to warrant substantial equivalence.
Sample Size Used for Test Set: This is not a "test set" in the context of clinical data for AI performance. The "test set" here refers to the device and its transducers undergoing various physical and electrical tests. No specific number of "tests" or "samples" (like patient cases) is provided, as it's a conformity assessment to standards.
Data Provenance: The data provenance is laboratory testing conducted by the manufacturer, SonoScape Company Limited, for regulatory submission to the FDA. It is not retrospective or prospective clinical data from human patients/cases.
Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. No human expert "ground truth" for diagnostic accuracy was established in this type of testing. The "ground truth" is adherence to the technical specifications of the standards.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is for evaluating human performance, often with or without AI assistance, which is not relevant to this submission.
Standalone (Algorithm Only) Performance: Not applicable. The device is an ultrasound system, not an AI algorithm.
Type of Ground Truth Used: Standards conformance and engineering specifications. The "ground truth" for this submission is that the device physically performs according to established industry safety and performance benchmarks. It is not based on expert consensus, pathology, or outcomes data from patient diagnoses.
Sample Size for the Training Set: Not applicable. This device does not describe an AI or machine learning component that would require a training set.
How the Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device (ultrasound system) based on substantial equivalence, which primarily relies on non-clinical testing for safety and basic performance characteristics against established standards and a predicate device. It does not describe a clinical performance study, especially not one involving AI or detailed human reader evaluation.

Summary

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K13/088
510(k) Submission Page 1 of 5

510(k) Summary

MAY 2 4 2013

[As required by 21 CFR 807 92]

1. Date Prepared [21 CFR807.92 (a) (1)]

March 30, 2012

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor:	SonoScape Company Limited
Address:	Yizhe Building, Yuquan Road, Nanshan, Shenzhen518051, P.R.China
Contact Name:	Zhou Wenping
Telephone No.:	+86 755 26722890
Fax No.:	+86 755 26722850
Email Address:	Zhou@sonoscape.net / Faith@sonoscape.net

3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

Trade Name:	S9 Portable Digital Color Doppler Ultrasound System
Common Name:	Diagnostic Ultrasound System and Transducers
Classification:
21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System		Product code: IYN
21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System		Product code: IYO
21 CFR892.1570 Diagnostic Ultrasonic Transducer		Product code: ITX
Classification Panel:	Radiology
Device Class:	II

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

The identified predicates within this submission are as follows:

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SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date – November 07, 2011).

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

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

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

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

7. Technological Characteristics [21 CFR 807.92(a)(6)]

No.	Probe	Type	FrequencyRange	Intended Use
1	C344	curved Array	2.0-5.0 MHz	Fetal / Abdominal/ Ob/GYN
2	C353	curved Array	2.0-6.0 MHz	Fetal / Abdominal/ Ob/GYN
No.	Probe	Type	FrequencyRange	Intended Use
3	C322	curved Array	2.0-6.0 MHz	Fetal / Abdominal/ Ob/GYN
4	VC6-2	curved Array	2.0-6.0 MHz	Fetal/ Abdominal/ Ob/GYN
5	6V1	Micro-curvedArray	4.0-8.0 MHz	Trans-rectalTrans-vaginal
6	6V3	Micro-curvedArray	5.0-9.0 MHz	Trans-rectalTrans-vaginal
7	L741	Linear Array	5.0-10.0 MHz	Small Organ (reast, thyroid, testes)Musculo-skeletal (Conventional)Peripheral vessel
8	L742	Linear Array	5.0-12.0 MHz	Small Organ (reast, thyroid, testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel
9	L752	Linear Array	5.0-12.0 MHz	Small Organ (reast, thyroid, testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel
10	2P2	Phase Array	1.0-5.0 MHz	AbdominalCephalic(neonatal and adult)Cardiac (neonatal and adult)
11	3P1	Phase Array	1.0-5.0 MHz	AbdominalCephalic(neonatal and adult)Cardiac (neonatal and adult)
12	5P2	Phase Array	3.0-8.0 MHz	PediatricNeonatal CephalicCardiac Pediatric
13	8P1	Phase Array	4.0-12.0 MHz	PediatricNeonatal CephalicCardiac Pediatric

Table 1 Transducer Information

510(k) Summary

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510(k) Submission

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

Safety Considerations:

510(k) Summary

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

The S9 Portable Digital Color Doppler Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-5and ISO 10993-10.

Testing:

Laboratory testing was conducted to verify that the S9 Portable Digital Color Doppler Ultrasound System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".

StandardsNo.	Standards Title	Version	Date
IEC 60601-1	Medical Electrical Equipment - Part1.General Requirements for Safety	1988+A1:1991+A2:1995	10/31/2005
IEC60601-1-2	Medical Electrical Equipment, Part 1-2:General Requirements for Safety –Collateral Standard: ElectromagneticCompatibility – Requirements and Tests	2007	03/01/2007
IEC60601-2-37	Medical Electrical Equipment, Part 2-37:Particular Requirements for the Safety ofUltrasonic Medical Diagnostic andMonitoring Equipment	2007	08/01/2007

Tab 2 Applicable Safety Standards

510(k) Summary i

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K/3/088

Portable Digital Color Doppler Ultrasound System

510(k) Submission

NEMA UD 2	Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment Version 3	2004	01/01/2004(R 2009)
NEMA UD3	Standard for Real-Time Display of Thermaland Mechanical Acoustic Output Indices onDiagnostic Ultrasound Equipment	2004	01/01/2004(R 2009)
ISO 10993-5	Biological evaluation of medical devices -Part 5: Tests for In Vitro cytotoxicity	1999	05/15/1999
ISO10993-10	Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-typehypersensitivity	2002	09/01/2002

Results of performance and compliance testing conducted on the S9 Portable Digital Color Doppler Ultrasound System, indicates conformance to all applicable standards recognized by FDA for this device.

Based on non-clinical test results, S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices in safety and effectiveness.

9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 24, 2013

SonoScape Company Limited % Ms. Toki Wu Yizhe Building, Yuquan Road, NanShan Shenzhen, Guangdong 518051 P.R. CHINA

Re: K131088

Trade/Device Name: S9 Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYN, IYO, and ITX Dated: March 26, 2013 Received: April 18, 2013

Dear Ms. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the S9 Portable Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P2 Phase Array 8P1 Phase Array C344 Curved Array VC6-2 Curved Array 3P1 Phase Array 6V1 Micro-curved Array C353 Curved Array L741 Linear Array L752 Linear Array

5P2 Phase Array 6V3 Micro-curved Array C322 Curved Array L742 Linear Array

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Page 2 - Ms. Toki Wu

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable; the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy, Ph.D. at (301) 796-6242.

Sincerely yours,

Smh.7)

for

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

Enclosures

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Portable Digital Color Doppler Ultrasound System

510(k) Submission

Indications for Use

K131088 510(k) Number (if known):

Device Name:

S9 Portable Digital Color Doppler Ultrasound System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR:807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(m-7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) = K131088

Indications for Use

Page 1 of 15

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System:

SonoScape S9

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	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	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,6
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
Fetal	Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
Imaging&Other	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)	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)	N	N	N		N	N	Note 1	Notes 2,4,5
	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
Cardiac	Intravascular(Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
Vessel	Other (specify)

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 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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

Indications for Use

Page 2 of 15

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Transducer: 2P2 Phase 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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic	N	N	N	N	N	N	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)
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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 M; B/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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

Indications for Use

Page 3 of 15

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Transducer: 3P1 Phase 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	Specific					Color	Power	Other*	Other*
(TRACK 1ONLY)	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude) Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1.	Notes 2,3,4
	Adult Cephalic	N	N	N	N	N	N	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)
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

Indications for Use

Page 4 of 15

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Transducer: 5P2 Phase 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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude) Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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

Note 3: TD! Note 4: 3D . · Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) __

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

Transducer: 8P1 Phase 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	Specific					Color	Power	Other*	Other*
(TRACK 1ONLY)	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude) Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) .

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

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						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging&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 2,4
	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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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 M; B/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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

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

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&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 2,4
	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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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 M; B/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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

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

Transducer: C344 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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	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
	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
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

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

Transducer: C353 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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	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
	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
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel

N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color

Doppler/PWD; B/Power Doppier/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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

Indications for Use

Page 10 of 15

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

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	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
	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
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

Indications for Use

Page 11 of 15

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

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	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)	P	P	P		P	P	Note 1	Notes 2,4,5
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) =

Indications for Use

Page 12 of 15

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

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						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Other (specify)

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 M; B/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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) ___

Indications for Use

Page 13 of 15

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

Transducer: L742 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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	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
	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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Other (specify)

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 M; B/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

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

Indications for Use

Page 14 of 15

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

Transducer: L752 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	Specific					Color	Power	Other*	Other*
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)	Combined	Specify
ONLY)							Doppler
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&	Abdominal
Other	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
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal	N	N	N		N	N	Note 1	Notes 2,4
	(Conventional)
	Musculo-skeletal	N	N	N		N	N	Note 1	Notes 2,4
	(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
Vessel	Other (specify)

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

Smh.7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K131088 510(k)

Indications for Use

Page 15 of 15

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.