The SonoScape S8 Exp 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 S8 Exp 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 SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is a general-purpose integrated, preprogrammed color ultrasound imaging system intended for diagnostic imaging.
The device's performance aligns with the predicate device, SonoScape S9 Portable Digital Color Doppler Ultrasound System (K131088).

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Predicate: SonoScape S9)	Reported Device Performance (SonoScape S8 Exp)
Intended Use	Identical	Identical
Classification	Identical	Identical
Product Code	Identical	Identical
Regulation Number	Identical	Identical
Panel	Identical	Identical
Class	II	II
Acoustic Track	TRACK 3	TRACK 3
Design	Embedded Linux System, 128 channel full digital beam former, Autocorrelation for color processing, FFT for pulse and CW Doppler, Supports Linear, Curve linear, and Phase array probes (2-15 MHz), Cine playback, Image archive, Software upgrade via USB, Digital Scan Converter 800x600	Identical (except for panel type)
Panel Type	Touch-screen panel	Full keyboard panel
Operation Control	TGC 8 slider, Depth Range: 3-32 cm, Image sector size: 32 lines to full B (256 lines), Image Sector position: Steering within full maximum, B orientation flip: L/R key with marking on screen, B Dynamic range control: 14 preset curves over 140 dB, Gray Scale Control: 7 Settings, Focal Number: 12, B persistence: 0-95%, Image Processing: Smoothing, edge enhancement, PW sweeping speed 2 4 6 8, PW Wall filter setting: 16 settings (25-750 HZ), PW sample volume: 0.5-20 mm, PW/B update: with UPDATE key, PW cursor steering: Steer soft key, PW angle correction: 0-80 degree user control, PW spectrum dynamic range: 10 preset curve over 15-48 dB, Spectrum baseline shift and invert, Color ROI setting: trackball and set key to control size and position, Color steering on flat probe: ±20 ±160, Color Wall Filter: 16 selection (25-750 of PRF), Color priority-B priority soft menu, Color Packet size: preset per Exam, Zoom adjustable, Freeze control: Toggling freeze key, Cine control: step, play backward, play continuously	Identical
Operation Mode	B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, 3D/4D Mode, Color M Mode	Identical
Display Modes	Dual B, Quad Display, B and M, B and Doppler, B + Color, Dual B(Flow), Triplex mode, Dual B and Color in real time, Compound Imaging, Panoramic Imaging, Trapezoid Imaging	Identical
Measurement Items	Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small part package	Identical
Cine Loop	Automatic review/ manual review, Review speed adjustable	Identical
Power Supply	Voltage: 110-240 VAC, Frequency: 50/60 Hz, Power Consumption: 110-240V AC, 2.7-1.2A	Identical
Operating Condition	Temperature: 10-40°C, Relative humidity: 30-75%, Air pressure: 700hPa-1060hPa	Identical
Storage Condition	Temperature: -20-55°C, Relative humidity: 20-90%, Air pressure: 700hPa-1060hPa	Identical
Screen Size	15 inch Widescreen LCD monitor	15 inch Widescreen LCD monitor
Measurement Accuracy	Display depth: Max 32.9 cm; ±3%, Distance: 0-31.0 cm; ±3%, Area: Max. ≥855 cm²; ±7%, Angle: 10-193°; ±3%, Circumference: 200 cm; ±3%, Volume: Max. 25000 cm³; ±10%, M-Mode time: 2,4,6,8 S; ±1%, Heart Rate: 8-1000 beats/sec; ±3%, Slope: 1300 cm/s; ±3%, Velocity (PW): 0.04-2940 cm/s; Angle ≤60°, ≤5%, Velocity (CW): 0.12-3795 cm/s; Angle ≤60°, ≤5%, Velocity (Color): 1-298 cm/s; Angle ≤60°, ≤5%	Identical
Acoustic Output	Track 3:MI, TIS, TIC, TIB, Derated ispta: 720Mw/cm² maximum. TIS/TIB/TIC: 6.0 Maximum, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190W/cm² max	Identical
Electrical Safety	-IEC 60601-1	-IEC 60601-1
EMC	-IEC 60601-1-2	-IEC 60601-1-2
Performance	-IEC 60601-2-37	-IEC 60601-2-37
Biocompatibility	-ISO 10993-5, -ISO 10993-10	-ISO 10993-5, -ISO 10993-10
Level of Concern of Software	Moderate level of concern system	Moderate level of concern system

2. Sample Size Used for the Test Set and Data Provenance

The document states that "No clinical testing was required." Therefore, there is no information on a test set, sample size, or data provenance from clinical data. The testing mentioned in the submission focuses on laboratory testing to verify design specifications and compliance with safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical testing was required, there is no adjudication method described.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned in this submission. The submission focuses on comparing the proposed device to a predicate device based on technical specifications and compliance with standards, not on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is an ultrasound system and not an AI algorithm. Therefore, the concept of standalone performance of an algorithm without human-in-the-loop is not applicable in the context of this submission. The performance assessment is related to the imaging capabilities of the hardware and software as a complete diagnostic tool used by a physician.

7. The Type of Ground Truth Used

Given that no clinical testing was required, the "ground truth" for demonstrating device performance relied on:

Compliance with Industry Standards: NEMA UID 2: 2004, NEMA UD3: 2004, IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-37: 2008, ISO 10993-5, ISO 10993-10.
Comparison to Predicate Device Specifications: The primary method for proving substantial equivalence was a direct comparison of technical specifications, intended use, and performance parameters (e.g., measurement accuracy, acoustic output) against the previously cleared predicate device (SonoScape S9, K131088).

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device, as it is a diagnostic ultrasound system and not an AI/machine learning algorithm requiring a training phase with a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/machine learning algorithm was involved.

Summary

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510(k) Submission

510(k) Summary

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

August 30, 2013

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:	Toki Wu
Telephone No.:	+86 755 26722890
Fax No.:	+86 755 26722850
Email Address:	Faith@sonoscape.net/wusq@sonoscape.net

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

Trade Name:	S8 Exp 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: SonoScape Company Limited, Portable Digital Color Doppler Ultrasound System, Model S9 has been cleared by FDA through 510(k) No.K131088 (May 24, 2013).

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

510(k) Summary

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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. Testing

Laboratory testing was conducted to verify that the S8 Exp system with added transducer met all design specification and was substantially equivalent to the Predicate Device. 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. 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".

IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. IEC 60601-2-37: 2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.

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NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

1. Clinical Test:
  No clinical testing was required.

9. Comparison Table

The differences between the S8 Exp and the predicate device S9 in almost every part are listed in the tables below.

ID	Items	Proposed DeviceSonoScape S8 Exp	Predicate DeviceSonoScape S9	Remark
1	IntendedUse	The SonoScape S8 Exp deviceis a general-purpose ultrasonicimaging instrument intended foruse by a qualified physician forevaluation of Fetal, Abdominal,Pediatric, Small Organ (breast,testes, thyroid),Cephalic(neonatal and adult),Trans-rectal, Trans-vaginal,Peripheral Vascular,Musculo-skeletal (Conventionaland Superficial), Cardiac(neonatal and adult), OB/Gynand Urology.	The SonoScape S9 device is ageneral-purpose ultrasonicimaging instrument intended foruse by a qualified physician forevaluation of Fetal, Abdominal,Pediatric, Small Organ (breast,testes, thyroid),Cephalic(neonatal and adult),Trans-rectal, Trans-vaginal,Peripheral Vascular,Musculo-skeletal (Conventionaland Superficial), Cardiac(neonatal and adult), OB/Gynand Urology.	Same

Table 1 Intended Use Comparison

Table 2 General Comparison

ID	ComparisonItems	Proposed DeviceSonoScape S8 Exp	Predicate DeviceSonoScape S9	Remark
2	ClassificationName	Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer	Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer	Same
3	ProductCode	90-IYN/90-IYO/90-ITX	90-IYN/90-IYO/90-ITX	Same
4	RegulationNumber	892.1550/892.1560/892.1570	892.1550/892.1560/892.1570	Same
ID	Comparison Items	Proposed Device SonoScape S8 Exp	Predicate Device SonoScape S9	Remark
5	Panel	Radiology	Radiology	Same
6	Class	II	II	Same
7	Probe Type & Connectors	L741 Linear Array, 5.0-10.0 MHzL742 Linear Array, 5.0-12.0 MHzL752 Linear Array, 5.0-12.0 MHzL743 Linear Array, 5.0-10.0 MHz10L1 Linear Array, 6.0-12.0 MHzC611 Micro-curved Array,4.0-8.0 MHzC311 Micro-curved Array,2.0-4.0 MHzC344 Curved Array, 2.0-5.0 MHzC322 Curved Array, 2.0-6.0 MHzC353 Curved Array, 2.0-6.0 MHzC362 Curved Array, 2.0-6.0 MHzC354 Curved Array, 2.0-6.0 MHzC542 Curved Array, 4.0-7.0 MHzVC6-2 Curved Array,2.0-6.0 MHz	L741 Linear Array, 5.0-10.0 MHzL742 Linear Array, 5.0-12.0 MHzL752 Linear Array, 5.0-12.0 MHz/	SEAnalysis1
		C344 Curved Array, 2.0-5.0 MHz
		C322 Curved Array, 2.0-6.0 MHz
		C353 Curved Array, 2.0-6.0 MHz
		VC6-2 Curved Array,2.0-6.0 MHz
		6V1 Micro-curved Array,4.0-8.0 MHz	6V1 Micro-curved Array,4.0-8.0 MHz
		6V3 Micro-curved Array,5.0-9.0 MHz	6V3 Micro-curved Array,5.0-9.0 MHz
		EC9-5 Micro-curved Array,5.0-9.0 MHz
		BCC9-5 Micro-convex Array.5.0-9.0MHz
		BCL10-5 Micro-convex Array,5.0-10.0MHz
		2P2 Phased Array, 1.0-5.0 MHz	2P2 Phased Array, 1.0-5.0 MHz
		3P1 Phased Array, 1.0-5.0 MHz	3P1 Phased Array, 1.0-5.0 MHz
		5P2 Phased Array, 3.0-8.0 MHz	5P2 Phased Array, 3.0-8.0 MHz
		8P1 Phased Array, 4.0-12.0 MHz	8P1 Phased Array, 4.0-12.0 MHz
		2P1 Phased Array, 2.0-4.0 MHz5P1 Phased Array, 4.0-7.0 MHz
		Multi-port connector connects 2 transducers	Multi-port connector connects 2 transducers
8	Acoustic Track	TRACK 3	TRACK 3	Same
ID	ComparisonItems	Proposed DeviceSonoScape S8 Exp	Predicate DeviceSonoScape S9	Remark
		Based on an embedded Linuxoperating system.	Based on an embeddedLinux operating system.	Same
		Based on a 128 channel fulldigital beam former.	Based on a 128 channel fulldigital beam former.	Same
		Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.	Autocorrelation for colorprocessing and FFT forpulse and CW Dopplerprocessing.	Same
9	Design	Supporting Linear, Curvelinear and Phase array probesfrom 2 to 15 MHz.	Supporting Linear, Curvelinear and Phase arrayprobes from 2 to 15 MHz.	Same
		Cine play back capability	Cine play back capability	Same
		Image file archive	Image file archive	Same
		Software upgrade with USBflash drive.	Software upgrade with USBflash drive.	Same
		Digital Scan Converter800×600	Digital Scan Converter800×600	Same
		With full keyboard panel	With touch-screen panel	SEAnalysis2
		TGC 8 slider	TGC 8 slider	Same
		Depth Range: 3 to 32 cm	Depth Range: 3 to 32 cm	Same
		Image sector size: 32 lines tofull B (256 lines)	Image sector size: 32 linesto full B (256 lines)	Same
		Image Sector position:Steering within full maximum	Image Sector position:Steering within full maximum	Same
	OperationControls	B orientation flip :L/R key withmarking on the screen	B orientation flip :L/R keywith marking on the screen	Same
10		B Dynamic range control:preset 14 curves over 140 dB	B Dynamic range control:preset 14 curves over 140 dB	Same
		Gray Scale Control: 7 Settings	Gray Scale Control: 7Settings	Same
		Focal Number: 12 focal zonesetting	Focal Number: 12 focal zonesetting	Same
		B persistence: 0-95%	B persistence: 0-95%	Same
		Image Processing: Smoothing,edge enhancement	Image Processing:Smoothing, edgeenhancement	Same
		PW sweeping speed 2 4 6 8	PW sweeping speed 2 4 6 8	Same

510(k) Summary

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510(k) Summary

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Table 3 Functions Comparison

510(k) Summary

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ID	Comparison	Proposed Device	Predicate Device	Remark
	ltems	SonoScape S8 Exp	SonoScape S9
		sec over display	sec over display
		PW Wall filter setting:16	PW Wall filter setting: 16	Same
		settings,25 to 750 HZ	settings,25 to 750 HZ
		PW sample volume:0.5 to	PW sample volume:0.5 to	Same
		20mm	20mm
		PW/B update: with UPDATE	PW/B update: with UPDATE	Same
		key	key
		PW cursor steering: Steer soft	PW cursor steering: Steer
		key	soft key	Same
		PW angle correction:0 to 80	PW angle correction:0 to 80
		degree user control	degree user control	Same
		PW spectrum dynamic	PW spectrum dynamic
		range:10 preset curve over	range:10 preset curve over	Same
		15-48 dB	15-48 dB
		Spectrum baseline shift and	Spectrum baseline shift and
		invert	invert	Same
		Color ROI setting: trackball	Color ROI setting: trackball
		and set key to control size and	and set key to control size	Same
		position	and position
		Color steering on flat	Color steering on flat	Same
		probe:±20 ±160	probe: ±20 ± 160
		Color Wall Filter: Color wall	Color Wall Filter: Color wall
		filter with 16 selection, 25-750	filter with 16 selection,	Same
		of PRF	25-750 of PRF
		Color priority-B priority soft	Color priority-B priority soft
		menu	menu	Same
			Color Packet size: preset
		Color Packet size: preset per	per Exam, horizontal,	Same
		Exam, horizontal, vertical, off	vertical, off
		Zoom adjustable	Zoom adjustable	Same
		Freeze control: Toggling	Freeze control: Toggling	Same
		freeze kev	freeze key
		Cine control: step, play	Cine control: step, play	Same
		backward, play continuously	backward, play continuously
	OperationMode	B, M, PW, CW, CFM, DPI, TDI,	B, M, PW, CW, CFM, DPI,
		Tissue Harmonic Image	TDI,
11		3D/4D Mode	Tissue Harmonic Image	Same
		Color M Mode	3D/4D Mode
			Color M Mode
12	Display	Dual B, Quad Display.	Dual B, Quad Display,
	Modes	B and M. B and Doppler	B and M. B and Doppler	Same

510(k) Summary

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ID	ComparisonItems	Proposed DeviceSonoScape S8 Exp	Predicate DeviceSonoScape S9	Remark
		B + Color, Dual B(Flow)Triplex mode: B,CFM, andPW/CW; B,DPI, andPW/CW;B,THI and Color M,steer MDual B and Color in real timeCompound Imaging,Panoramic Imaging.Trapezoid Imaging.	B + Color, Dual B(Flow)Triplex mode: B,CFM, andPW/CW; B,DPI, andPW/CW;B,THI and Color M,steer MDual B and Color in real timeCompound Imaging,Panoramic Imaging,Trapezoid Imaging.
13	Measurement Items	Distance; area; circumference;calipers; volume, velocity, HR,PI, RI. Cardiac. OB/GYN,Urology, Vascular and smallpart package	Distance; area;circumference; calipers;volume, velocity, HR, PI, RI.Cardiac: OB/GYN, Urology.Vascular and small partpackage	Same
14	Cine Loop	Automatic review/ manualreviewReview speed can be adjusted	Automatic review/ manualreviewReview speed can beadjusted	Same

Table 4 Specifications Comparison

ID	ComparisonItems	Proposed DeviceSonoScape S8 Exp	Predicate DeviceSonoScape S9	Remark
15	PowerSupply	Voltage: 110-240 VACFrequency: 50/60 HzPower Consumption: 110-240V AC, 2.7-1.2A	Voltage: 110-240 VACFrequency: 50/60 HzPower Consumption: 110-240V AC, 2.7-1.2A	Same
		16	OperatingCondition	Temperature: 10~~40°CRelative humidity: 30~~75%Air pressure: 700hPa ~1060hPa	Temperature: 10~~40°CRelative humidity: 30~~75%Air pressure: 700hPa ~1060hPa	Same
		17	StorageCondition	Temperature: -20~~55°CRelative humidity: 20~~90%Air pressure: 700hPa ~1060hPa	Temperature: -20~~55°CRelative humidity: 20~~90%Air pressure: 700hPa ~1060hPa	Same
18	Screen Size	15 inch Widescreen LCD monitor	15 inch Widescreen LCD monitor	Same
19	MeasurementAccuracy	Parameter: Display depthValue range: Max 32.9 cm; (Probe depend)Error range: ±3%	Parameter: Display depthValue range: Max 32.9 cm; (Probe depend)Error range: ±3%	Same

510(k) Summary

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SonoScape Company Limited

510(k) Submission

ID	ComparisonItems		Proposed DeviceSonoScape S8 Exp		Predicate DeviceSonoScape S9	Remark
		Distance	0~31.0 cm	±3%	Distance	0~31.0 cm	±3%	Same
		Area	Max. ≥855 cm²	±7%	Area	Max. ≥855 cm²	±7%	Same
		Angle	10~193°	±3%	Angle	10~193°	±3%	Same
		Circumference	200 cm	±3%	Circumference	200 cm	±3%	Same
		Volume	Max. 25000 cm³	±10%	Volume	Max. 25000 cm³	±10%	Same
		M-Mode time	2,4,6,8 S	±1%	M-Mode time	2,4,6,8 S	±1%	Same
		Heart Rate	8~1000 beats/sec	±3%	Heart Rate	8~1000 beats/sec	±3%	Same
		Slope	1300 cm/s	±3%	Slope	1300 cm/s	±3%	Same
		Velocity (PW)	0.04-2940 cm/s	Angle ≤60°, ≤5%	Velocity (PW)	0.04-2940 cm/s	Angle ≤60°, ≤5%	Same
		Velocity (CW)	0.12-3795 cm/s	Angle ≤60°, ≤5%	Velocity (CW)	0.12-3795 cm/s	Angle ≤60°, ≤5%	Same
		Velocity (Color)	1-298 cm/s	Angle ≤60°, ≤5%	Velocity (Color)	1-298 cm/s	Angle ≤60°, ≤5%	Same
20	Acoustic Output	Track 3:MI, TIS, TIC, TIBDerated ispta: 720Mw/cm² maximum.			Track 3: MI, TIS, TIC, TIBDerated ispta: 720Mw/cm² maximum.			Same
		TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9Maximum, or Derated Isppa:			TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9Maximum, or Derated Isppa:
		190W/cm² max			190W/cm² max

Table 5 Safety Comparison

ID	Comparison Items	Proposed DeviceSonoScape S8 Exp	Predicate DeviceSonoScape S9	Remark
21	Electrical Safety	-IEC 60601-1	-IEC 60601-1	Same
22	EMC	-IEC 60601-1-2	-IEC 60601-1-2	Same
23	Performance	-IEC 60601-2-37	-IEC 60601-2-37	Same
24	Biocompatibility	-ISO 10993-5,-ISO 10993-10	-ISO 10993-5,-ISO 10993-10	Same
25	Level of Concern OfSoftware	Moderate level ofconcern system	Moderate level ofconcern system	Same

510(k) Summary

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K132768
Page 9 of 9

510(k) Submission

SE Analysis 1:

Probe Type, Compare to the predicate device, the proposed device is with different probe type or frequency, such as L743, 10L1, C611, C311 etc. But no new intended use is added and all of them comply with IEC 60601-2-37, NEMA UD 2-2004 and NEMA UD3: 2004, therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

SE Analysis 2:

The proposed device is with full keyboard panel and the predicate device is not, but both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

Discussion of Substantially Equivalent

It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).

The proposed device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

10 Substantially Equivalent Conclusions

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 S8 Exp Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the figure. The figure is black, and the text is also black.

Public Health Service

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

October 4, 2013

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

Re: K132768

Trade/Device Name: S8 Exp Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 30, 2013 Received: September 4, 2013

Dear Ms. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the "S8 Exp Portable Digital Color.Doppler Ultrasound System," as described in your premarket notification:

Transducer Model Number

2P1 Phase Array 5P1 Phase Array C611 Micro-curved Array 6V3 Micro-curved Array BCL10-5 Biplane Array C354 Curved Array C322 Curved Array L742 Linear Array

2P2 Phase Array 5P2 Phase Array C311 Micro-curved Array EC9-5 Micro-curved Array C344 Curved Array C542 Curved Array VC6-2 Curved Array L743 Linear Array 10L1 Linear Array

3P1 Phase Array 8P1 Phase Array 6V1 Micro-curved Array BCC9-5 Micro-curved Array C353 Curved Array C362 Curved Array L741 Linear Array L752 Linear Array

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Page 2—Ms. Wu

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address > http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

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

Enclosure

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

Indications for Use

K132768 510(k) Number: S8 Exp Portable Digital Color Doppler Ultrasound System Device Name:

Indications for Use: The SonoScape S8 Exp 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, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Prescription Use _ _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

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

$m.h.7).

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

K132768 510(k) _

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

System: SonoScape S8 Exp

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
FetalImaging&Other	Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	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
	Intravascular(Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Other (specify)

P = previously cleared by FDA: E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color 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 4: 3D Note 5: 4D Note 3: TDI

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: 2P1 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)

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

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

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	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro				—
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color 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 4: 3D Note 5: 4D Note 3: TDI

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

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: 5P1 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						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	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)
	Other (Urology)
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)

P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color 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 4: 3D 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) _______________________________________________________________________________________________________________________________________________________________________

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

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	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	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	P	P	P	P	P	P	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 4: 3D Note 5: 4D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

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

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

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

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

Transducer: C611 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	N	N	N		N	N	Note 1	Notes 2,4
	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)
	Other (Urology)
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: 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) __

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

Transducer: C311 Micro-curved Array

SonoScape Company Limited

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
Fetal	Fetal
Imaging&Other	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	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)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	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) _______________________________________________________________________________________________________________________________________________________________________

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

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 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)

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

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

510(k) __

{22}------------------------------------------------

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						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)
Cardiac	Intravascular
	Other (Ob/GYN)
	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 4: 3D Note 5: 4D Note 3: TDI

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

{23}------------------------------------------------

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 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	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
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 4: 3D Note 5: 4D Note 3: TDI
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

{24}------------------------------------------------

Transducer: BCC9-5 Micro-curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						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	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
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

{25}------------------------------------------------

Transducer: BCL10-5 Biplane Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						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	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
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) __

{26}------------------------------------------------

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						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	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 5: 4D Note 3: TDI Note 4: 3D

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

{27}------------------------------------------------

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						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	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) __

{28}------------------------------------------------

Transducer: C354 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	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

{29}------------------------------------------------

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						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	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	N	N	N		N	N	Note 1	Notes 2,4
	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)
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 4: 3D 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

{30}------------------------------------------------

Transducer: C362 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	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

{31}------------------------------------------------

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					Other
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	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)
Peripheral	Peripheral vessel

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) _

{32}------------------------------------------------

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	OtherCombined	OtherSpecify
Ophthalmic	Ophthalmic
Fetal	Fetal	p	P	P		P	P	Note 1	Notes 2,4,5
Imaging &	Abdominal	P	P	p		P	P	Note 1	Notes 2,4,5
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Ob/GYN)	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)
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) _______________________________________________________________________________________________________________________________________________________________________

{33}------------------------------------------------

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	Specific	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
(TRACK 1ONLY)	(TRACKS 1 & 3)
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)

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

{34}------------------------------------------------

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	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	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)

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 3D Note 5: 4D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

{35}------------------------------------------------

Transducer: L743 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)	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(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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	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) _______________________________________________________________________________________________________________________________________________________________________

{36}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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(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)

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

{37}------------------------------------------------

and the same of the same of the same of the same of the same of the same of

Transducer: 10L1 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)	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(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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	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

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.