The SonoScape S40 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 S40 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

This document describes the SonoScape S40 Digital Color Doppler Ultrasound System and its substantial equivalence to a predicate device (SonoScape S6). The information provided is primarily for regulatory submission and does not detail a clinical study with an acceptance criterion for device performance in the way a clinical trial for an AI algorithm would. Instead, it focuses on technical specifications and compliance with safety standards to demonstrate substantial equivalence.

Based on the provided text, a "study" in the sense of a clinical performance study with human readers or standalone algorithm performance, as typically found in AI/ML device submissions, was not conducted. The study supporting this device's acceptance is a bench testing and comparison study against a predicate device and relevant safety standards.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the performance characteristics of the predicate device (SonoScape S6) and compliance with international safety and performance standards. The "reported device performance" is the comparison of the SonoScape S40 against the S6.

Feature / Parameter	Acceptance Criteria (Predicate Device S6 Performance)	Reported Device Performance (SonoScape S40)	Remark
Intended Use	General-purpose ultrasonic imaging for Fetal, Abdominal, Pediatric, Small Organ, Cephalic, Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal, Cardiac, OB/Gyn, Urology.	Same	Same (Substantially Equivalent)
Classification	Same as predicate: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer; Class II; Product Code IYN, IYO, ITX.	Same	Same (Substantially Equivalent)
Supported Probes	Specific list of Linear, Curved, Micro-curved, and Phased Array probes.	Includes new L752, C353, C322, 5P2, 8P1 probes, and different configuration of Phased Array probes (2P2, 3P1). Handles from 2 to 15 MHz.	Differences noted, but all comply with IEC 60601-2-37. Considered Substantially Equivalent in safety and effectiveness; no new risk. New probes potentially offer improved image quality.
Channel Beam Former	64 channel full digital beam former.	128 channel full digital beam former.	S40 has better image quality due to 128 channels. Considered Substantially Equivalent in safety and effectiveness.
Image Sector Size	32 lines to full B (256 lines).	32 lines to full B (512 lines).	S40 has better image quality due to 512 lines. Considered Substantially Equivalent in safety and effectiveness.
Display Depth	Max 32.9 cm; (Probe depend); Error range: ±3%.	Same (Max 32.9 cm; (Probe depend); Error range: ±3%).	Same (Substantially Equivalent)
Distance Measurement	0~31.0 cm; Error range: ±3%.	Same (0~31.0 cm; Error range: ±3%).	Same (Substantially Equivalent)
Area Measurement	Max. ≥855 cm²; Error range: ±7%.	Same (Max. ≥855 cm²; Error range: ±7%).	Same (Substantially Equivalent)
Angle Measurement	10~193°; Error range: ±3%.	Same (10~193°; Error range: ±3%).	Same (Substantially Equivalent)
Circumference Measurement	200 cm; Error range: ±3%.	Same (200 cm; Error range: ±3%).	Same (Substantially Equivalent)
Volume Measurement	Max. 25000 cm³; Error range: ±10%.	Same (Max. 25000 cm³; Error range: ±10%).	Same (Substantially Equivalent)
M-Mode Time	2,4,6,8 S; Error range: ±1%.	Same (2,4,6,8 S; Error range: ±1%).	Same (Substantially Equivalent)
Heart Rate	8 ~ 1000 beats/sec; Error range: ±3%.	Same (8 ~ 1000 beats/sec; Error range: ±3%).	Same (Substantially Equivalent)
Slope	1300 cm/s; Error range: ±3%.	Same (1300 cm/s; Error range: ±3%).	Same (Substantially Equivalent)
Velocity (PW)	0.04-2940 cm/s; Angle ≤60°, ≤5% error.	Same (0.04-2940 cm/s; Angle ≤60°, ≤5% error).	Same (Substantially Equivalent)
Velocity (CW)	0.13-3529 cm/s; Angle ≤60°, ≤5% error.	0.12-3795 cm/s; Angle ≤60°, ≤5% error.	S40 has better/wider velocity range. Considered Substantially Equivalent in safety and effectiveness.
Velocity (Color)	2-226 cm/s; Angle ≤60°, ≤5% error.	1-298 cm/s; Angle ≤60°, ≤5% error.	S40 has better/wider velocity range. Considered Substantially Equivalent in safety and effectiveness.
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).	Same (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).	Same (Substantially Equivalent) - Measured and calculated per NEMA UD 2: 2004.
Electrical Safety	Complies with IEC 60601-1.	Complies with IEC 60601-1.	Same (Substantially Equivalent)
EMC	Complies with IEC 60601-1-2.	Complies with IEC 60601-1-2.	Same (Substantially Equivalent)
Performance (Safety)	Complies with IEC 60601-2-37.	Complies with IEC 60601-2-37.	Same (Substantially Equivalent)
Biocompatibility	Complies with ISO 10993-5, ISO 10993-10.	Complies with ISO 10993-5, ISO 10993-10.	Same (Substantially Equivalent)
Level of Concern of Software	Moderate.	Moderate.	Same (Substantially Equivalent)

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

Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study on patients. The testing involved laboratory testing to verify design specifications and compliance with standards. It's implied that various transducers were tested for their acoustic output and safety characteristics.
Data Provenance: The testing was conducted internally by SonoScape Company Limited ("Laboratory testing was conducted to verify that the S40 system with added transducer met all design specification..."). The country of origin for the data would be China, where SonoScape is based.
Retrospective or Prospective: This was likely prospective bench testing and engineering validation against predefined specifications and standards, rather than retrospective or prospective clinical data collection from patients.

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

This type of information is not provided in the 510(k) summary. The submission does not describe a clinical study requiring human expert ground truth for interpretation of images. The ground truth for the technical measurements and safety compliance would be established by validated test equipment and calibration standards, assessed by qualified engineers and technicians, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. Given that no clinical test with human experts interpreting results was conducted, an adjudication method like 2+1 or 3+1 is not relevant to this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "No clinical testing was required." (Section 8). The comparison was primarily technical specifications against a predicate device.

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

Not applicable / No. This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic interpretation. Its performance is evaluated based on its ability to acquire and display ultrasound data accurately and safely, matching or improving upon the predicate device's technical specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the acceptance of this device relies on:
- Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed SonoScape S6 ultrasound system.
- International Safety and Performance Standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD3, ISO 10993-5, and ISO 10993-10.
- Bench Test Results: Direct measurements of technical parameters (e.g., measurement accuracy for distance, area, velocity, acoustic output) using calibrated equipment.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware and software system, not an AI/ML algorithm that is "trained" on a specific dataset. Its development involves standard engineering design, testing, and validation processes.

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

Not applicable. As there is no "training set" in the AI/ML sense, there is no ground truth established for one. The device's functionality is based on established ultrasound physics and engineering principles.

Summary

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510(k) Submission

510(k) Summary

JUN 2 1 2013

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

The assigned 510(k) number: K131213

1. Date of submission: April 26, 2013
1. Submitter

SonoScape Company Limited Address: Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China Tel: (86) 755-26722890 Fax: (86) 755-26722850 Contact Person: Toki Wu E-mail:Faith@sonoscape.net/wusq@sonoscape.net

3. Proposed Device Identification

Trade/Proprietary Name: S40 Digital Color Doppler Ultrasound System Common Name: Diagnostic Ultrasound System and Transducers Classification:

21 FR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)

21 FR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Classification Panel: Radiology

Device Class: Il

4. Legally Marketed Predicate Device

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

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5. Device Description

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 Statement

Transducer Information is shown in the table 1.

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
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-curved	5.0-9.0 MHz	Trans-rectal

Table 1 Transducer Information

510(k) Summary

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510(k) Submission

No.	Probe	Type	FrequencyRange	Intended Use
		Array		Trans-vaginal
7	L741	Linear Array	5.0-10.0 MHz	Small Organ (breast, thyroid, testes)Musculo-skeletal (Conventional)Peripheral vessel
8	L742	Linear Array	5.0-12.0 MHz	Small Organ (breast, thyroid, testes)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Peripheral vessel
9	L752	Linear Array	5.0-12.0 MHz	Small Organ (breast, 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

7. Testing

Laboratory testing was conducted to verify that the S40 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".

510(k) Summary

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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
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

Tab 2 Applicable Safety Standards

8. Clinical Test:

No clinical testing was required.

9. Comparison Table

The differences between the S40 and the predicate device S6 in almost every part are listed in the tables below.

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ID	Items	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	Remark
1	Intended Use	The device is ageneral-purpose ultrasonicimaging instrumentintended for use by aqualified physician forevaluation of Fetal,Abdominal, Pediatric, SmallOrgan (breast, testes,thyroid), Cephalic (neonataland adult), Trans-rectal,Trans-vaginal, PeripheralVascular, Musculo-skeletal(Conventional andSuperficial), Cardiac(neonatal and adult),Urology and OB/Gyn.	The device is ageneral-purpose ultrasonicimaging instrumentintended for use by aqualified physician forevaluation of Fetal,Abdominal, Pediatric, SmallOrgan (breast, testes,thyroid), Cephalic(neonataland adult), Trans-rectal,Trans-vaginal, PeripheralVascular, Musculo-skeletal(Conventional andSuperficial), Cardiac(neonatal and adult),OB/Gyn and Urology.	Same

Table 3 Intended Use Comparison

Table 4 General Comparison

ID	Comparison Items	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	Remark
2	Classification Name	Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer	Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer	Same
3	Product Code	90-IYN/90-IYO/90-ITX	90-IYN/90-IYO/90-ITX	Same
4	Regulation Number	892.1550/892.1560/892.1570	892.1550/892.1560/892.1570	Same
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 MHz	L741 Linear Array, 5.0-10.0 MHzL742 Linear Array, 5.0-12.0 MHzL743 Linear Array, 5.0-10.0 MHz	SEAnalysis1

510(k) Summary

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510(k) Submission

ID	ComparisonItems	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	Remark
		C344 Curved Array, 2.0-5.0MHzC322 Curved Array, 2.0-6.0MHzC353 Curved Array, 2.0-6.0MHz	C344 Curved Array, 2.0-5.0MHzC362 Curved Array, 2.0-6.0MHz
			C611 Micro-curved Array,4.0-8.0 MHz
		VC6-2 Curved Array, 2.0-6.0MHz6V1 Micro-curved Array,4.0-8.0 MHz6V3 Micro-curved Array,5.0-9.0 MHz	VC6-2 Curved Array, 2.0-6.0MHz6V1 Micro-curved Array,4.0-8.0 MHz6V3 Micro-curved Array,5.0-9.0 MHzEC9-5 Micro-curved Array,5.0-9.0 MHz
		2P2 Phased Array, 1.0-5.0MHz3P1 Phased Array, 1.0-5.0MHz5P2 Phased Array, 3.0-8.0MHz8P1 Phased Array, 4.0-12.0MHzMulti-port connector connects	2P1 Phased Array, 2.0-4.0MHz5P1 Phased Array, 4.0-7.0MHzMulti-port connector connects
		4 transducers	2 transducers
8	AcousticTrack	TRACK 3	TRACK 3	Same

Table 5 Functions Comparison

510(k) Summary

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510(k) Submission

510(k) Summary

8-7

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510(k) Submission .

510(k) Summary

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510(k) Submission

Table 6 Specifications Comparison

ID	ComparisonItems	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	Remark
15	PowerSupply	Voltage: 110-127/220-240 VACFrequency: 50/60 HzPower Consumption: 450VA	Voltage: 110-240 VACFrequency: 50/60 HzPower Consumption: 110-240V AC, 2.7-1.2A	SEAnalysis5
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	18.5 inch Widescreen LCDmonitor	15 inch Widescreen LCD monitor	SEAnalysis6
19	MeasurementAccuracy	Parameter	Value range	Errorrange	Parameter	Value range	Errorrange
		Displaydepth	Max 32.9 cm; (Probedepend)	±3%	Displaydepth	Max 32.9 cm; (Probedepend)	±3%	Same
		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-Modetime	2,4,6,8 S	±1%	M-Modetime	2,4,6,8 S	±1%	Same
		HeartRate	8 ~ 1000beats/sec	±3%	HeartRate	8 ~ 1000beats/sec	±3%	Same
	Slope	1300 cm/s	±3%	Slope	1300 cm/s	±3%	Same

510(k) Summary

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510(k) Submission

ID	Comparison Items	Proposed Device SonoScape S40		Predicate Device SonoScape S6		Remark
		Velocity	Angle	Velocity	Angle
	Velocity (PW)	0.04-2940 cm/s	≤60°, ≤5%	0.04-2940 cm/s	≤60°, ≤5%	Same
	Velocity (CW)	0.12-3795 cm/s	≤60°, ≤5%	0.13-3529 cm/s	≤60°, ≤5%	SE Analysis 7
	Velocity (Color)	1-298 cm/s	≤60°, ≤5%	2-226cm/s	≤60°, ≤5%
20	Acoustic Output	Track 3:MI, TIS, TIC, TIBDerated ispta: 720Mw/cm2 maximum.TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9 Maximum,or Derated Isppa: 190W/cm2 max
		Same

Table 7 Safety Comparison

ID	Comparison Items	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	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 ConcernOf Software	Moderate level ofconcern system	Moderate level ofconcern system	Same

SE Analysis 1:

Probe Type & Connectors, Compare to the predicate device, the proposed device is with different probe type or frequency, such as L752, C353 etc. But no new intended use is added and all of them comply with IEC 60601-2-37; And the proposed device has 4 probe connection ports and the predicate device has 2 probe connection ports, 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, and no new risk is raised, so the SE is not affected.

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SE Analysis 2: ·

The proposed device is based on a 128 channel full digital beam former and the predicate device is 64, but the 128 channel is better than 64 channel in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

SE Analysis 3:

The predicate device is with full keyboard and the proposed 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.

SE Analysis 4:

The proposed device is with 512 lines image sector size and the predicate device is 256, but the 512 lines is better than 256 lines in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

SE Analysis 5

The Power Supply of the proposed device and the predicate device are 110-127/220-240 VAC, 450VA and 110-240VAC, 2.7-1.2A respectively, but both of them comply with IEC60601-1 and IEC 60601-1-2. Therefore, power supply can be considered Substantially Equivalent in safety and effectiveness.

SE Analysis 6

The screen size of the proposed is larger than that of the S6. This difference is considered to have no effect on effectiveness and safety.

SE Analysis 7:

The proposed device and the predicate device are with different measurement accuracy in Velocity (CW/ Color), but the proposed device is better. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

Discussion of Substantially Equivalent

The subject device has same intended use, similar product design, and 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

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K131213
Page 12 of 12

510(k) Submission

principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

10. Substantially Equivalent Conclusion

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 S40 Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

510(k) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.

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

June 21, 2013

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

Re: K131213

Trade/Device Name: S40 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: April 26, 2013 Received: May 2, 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 S40 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 3PI 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 cither 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/About/DA/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/ReportalProblem/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 Shing Chun Benny Lam, Ph.D. at (301) 796-9328.

Sincerely yours,

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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Indications for Use

510(k) Number:	K131213
Device Name:	S40 Digital Color Doppler Ultrasound System
Indications for Use:	The SonoScape S40 device is a general-purpose ultrasonicimaging instrument intended for use by a qualifiedphysician for evaluation of Fetal, Abdominal, Pediatric,Small Organ (breast, testes, thyroid), Cephalic(neonataland adult), Trans-rectal, Trans-vaginal, PeripheralVascular, Musculo-skeletal (Conventional and Superficial),Cardiac (neonatal and adult), OB/Gyn and Urology.

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(x-h)

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K131213 510(k) _

Indications for Use

Page 1 of 15

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System: SonoScape S40

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&	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
Other	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)

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

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Indications for Use

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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)

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

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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(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 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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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)

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: TD! Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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Indications for Use

Page 5 of 15

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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(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)

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 Doppier; 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

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Indications for Use

Page 6 of 15

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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	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 5: 4D Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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Indications for Use

Page 7 of 15

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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	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

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Indications for Use

Page 8 of 15

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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

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510(k) _

Indications for Use

Page 9 of 15

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

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	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)

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

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Indications for Use

Page 10 of 15

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

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	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

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510(k) _

Page 11 of 15

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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	Specific					Color	· Power	Other	Other
(TRACK 1ONLY)	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
lmaging &	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)

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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Indications for Use

Page 12 of 15

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Transducer: L741 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General(TRACK 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	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	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 4: 3D Note 5: 4D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

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Indications for Use

Page 13 of 15

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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
Fetal	Fetal
Imaging&Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	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

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Indications for Use

Page 14 of 15

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Transducer: L752 Linear Array

Diagnostic Ultrasound Transducer

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)	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)

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

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

Note 6: Small Organ: breast, thyroid, testes
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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.

ID	ComparisonItems	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	Remark
9		Based on an embedded Linuxoperating system.	Based on an embedded Linuxoperating system.	Same
	Design	Based on a 128 channel fulldigital beam former.	Based on a 64 channel fulldigital beam former.	SEAnalysis2
		Autocorrelation for colorprocessing and FFT for pulse	Autocorrelation for colorprocessing and FFT for pulse	Same
ID	ComparisonItems	Proposed DeviceSonoScape S40and CW Doppler processing.	Predicate DeviceSonoScape S6and CW Doppler processing.	Remark
		Supporting Linear, Curve linearand Phase array probes from 2to 15 MHz.	Supporting Linear, Curve linearand Phase array probes from 2to 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 touch panel	With full keyboard	SEAnalysis3
		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 (512 lines)	Image sector size: 32 lines tofull B (256 lines)	SEAnalysis4
		Image Sector position: Steeringwithin full maximum	Image Sector position: Steeringwithin full maximum	Same
		B orientation flip :L/R key withmarking on the screen	B orientation flip :L/R key withmarking on the screen	Same
		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: 7 Settings	Same
		Focal Number: 12 focal zonesetting	Focal Number: 12 focal zonesetting	Same
10	OperationControls	B persistence: 0-95%	B persistence: 0-95%	Same
		Image Processing: Smoothing,edge enhancement	Image Processing: Smoothing,edge enhancement	Same
		PW sweeping speed 2,4,6,8sec over display	PW sweeping speed 2,4,6,8sec over display	Same
		PW Wall filter setting:16settings,25 to 750 HZ	PW Wall filter setting:16settings,25 to 750 HZ	Same
		PW sample volume:0.5 to20mm	PW sample volume:0.5 to20mm	Same
		PW/B update: with UPDATEkey	PW/B update: with UPDATEkey	Same
		PW cursor steering: Steer softkey	PW cursor steering: Steer softkey	Same
		PW angle correction:0 to 80degree user control	PW angle correction:0 to 80degree user control	Same
ID	Comparison Items	Proposed Device SonoScape S40	Predicate Device SonoScape S6	Remark
		PW spectrum dynamic range:10 preset curve over 15-48 dB	PW spectrum dynamic range:10 preset curve over 15-48 dB	Same
		Spectrum baseline shift and invert	Spectrum baseline shift and invert	Same
		Color ROI setting: trackball and set key to control size and position	Color ROI setting: trackball and set key to control size and position	Same
		Color steering on flat probe: $\pm$ 20, $\pm$ 16,0	Color steering on flat probe: $\pm$ 20, $\pm$ 16,0	Same
		Color Wall Filter: Color wall filter with 16 selection, 25-750 of PRF	Color Wall Filter: Color wall filter with 16 selection, 25-750 of PRF	Same
		Color priority-B priority soft menu	Color priority-B priority soft menu	Same
		Color Packet size: preset per Exam, horizontal, vertical, off	Color Packet size: preset per Exam, horizontal, vertical, off	Same
		Zoom adjustable	Zoom adjustable	Same
		Freeze control: Toggling freeze key	Freeze control: Toggling freeze key	Same
		Cine control: step, play backward, play continuously	Cine control: step, play backward, play continuously	Same
11	Operation Mode	B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image 3D/4D Mode Color M Mode	B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image 3D/4D Mode Color M Mode	Same
12	Display Modes	Dual B, Quad Display, B and M, B and Doppler B + Color, Dual B(Flow) Triplex mode: B,CFM, and PW/CW; B,DPI, and PW/CW;B,THI and Color M, steer M Dual B and Color in real time Compound Imaging, Panoramic Imaging, Trapezoid Imaging.	Dual B, Quad Display, B and M, B and Doppler B + Color, Dual B(Flow) Triplex mode: B,CFM, and PW/CW; B,DPI, and PW/CW;B,THI and Color M, steer M Dual B and Color in real time Compound Imaging, Panoramic Imaging, Trapezoid Imaging.	Same
13	Measurement Items	Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small	Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small	Same
ID	ComparisonItems	Proposed DeviceSonoScape S40	Predicate DeviceSonoScape S6	Remark
		part package	part package
14	Cine Loop	Automatic review/ manualreview	Automatic review/ manualreview	Same
		Review speed can be adjusted	Review speed can be adjusted	Same