The SonoScape S30 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, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.

Device Description

The SonoScape S30 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 510(k) submission (K132527 for the SonoScape S30 Digital Color Doppler Ultrasound System) does not contain a study comparing the device's performance to specific acceptance criteria. Instead, it relies on a substantial equivalence (SE) comparison to a legally marketed predicate device (SonoScape SSI-8000, K102642).

The document explicitly states: "No clinical testing was required" (Section 8, page 2). This indicates that a study demonstrating the device meets quantified acceptance criteria through clinical performance was not performed for this submission.

The acceptance criteria are implicitly defined by the parameters and performance of the predicate device, with the claim that the proposed device either matches or is "better" in certain aspects without raising new safety or effectiveness concerns.

Here's the breakdown of the requested information based on the provided text, while acknowledging the lack of a traditional performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Since there isn't a direct "acceptance criteria" table with specific thresholds, the comparison table from the 510(k) summary (Table 4: Specifications Comparison, page 7-8) serves as the de facto acceptance target, with the predicate device's performance being the benchmark. "Acceptance" here means demonstrating equivalence or superiority without introducing new risks.

ID	Comparison Items	Acceptance Criteria (Predicate Device SSI-8000)	Reported Device Performance (Proposed Device S30)	Evaluation (Remark from document)
15	Power Supply (Voltage)	100/220VAC	110-127/220-240 VAC	SE Analysis 4
15	Power Supply (Power Cons.)	330 VA	450VA	SE Analysis 4
16	Operating Condition (Temp)	10~40°C	10~40°C	Same
16	Operating Condition (Humid.)	30~75%	30~75%	Same
16	Operating Condition (Pressure)	700hPa ~1060hPa	700hPa ~1060hPa	Same
17	Storage Condition (Temp)	-20~55°C	-20~55°C	Same
17	Storage Condition (Humid.)	20~90%	20~90%	Same
17	Storage Condition (Pressure)	700hPa ~1060hPa	700hPa ~1060hPa	Same
18	Screen Size	17 inch LCD color monitor	19 inch Widescreen LCD monitor	SE Analysis 5
19	Measurement Accuracy (Display Depth)	Max 32.9cm; (Probe depend), ±3%	Max 32.9cm; (Probe depend), ±3%	Same
19	Measurement Accuracy (Distance)	0~31.0cm, ±3%	0~31.0cm, ±3%	Same
19	Measurement Accuracy (Area)	Max. ≥855cm², ±7%	Max. ≥855cm², ±7%	Same
19	Measurement Accuracy (Angle)	10~193° (Probe depend), ±3%	10~193°, ±3%	Same
19	Measurement Accuracy (Circumference)	200 cm, ±3%	200 cm, ±3%	Same
19	Measurement Accuracy (Volume)	Max. 25000 cm³, ±10%	Max. 25000 cm³, ±10%	Same
19	Measurement Accuracy (M-Mode time)	2,4,6,8S, ±1%	2,4,6,8S, ±1%	Same
19	Measurement Accuracy (Heart Rate)	8-1000 beats/sec, ±3%	8-1000 beats/sec, ±3%	Same
19	Measurement Accuracy (Slope)	1300 cm/s, ±3%	1300 cm/s, ±3%	Same
19	Measurement Accuracy (Velocity(PW))	0.04-2940 cm/s, Angle ≤60°, ≤5%	0.04-2940 cm/s, Angle ≤60°, ≤5%	Same
19	Measurement Accuracy (Velocity(CW))	0.13-3529 cm/s, Angles 60°, ≤5%	0.12-3795 cm/s, Angle ≤60°, ≤5%	SE Analysis 6 (Proposed better)
19	Measurement Accuracy (Velocity(Color))	2-226cm/s, Angles 60°, ≤5%	1-298 cm/s, Angle ≤60°, ≤5%	SE Analysis 6 (Proposed better)
20	Acoustic Output	Track 3:MI,TIS,TIC,TIB; Derated ispta: 720Mw/cm² max; TIS/TIB/TIC: 6.0 Max; MI: 1.9 Max; Derated Isppa: 190W/cm² max	Track 3:MI,TIS,TIC,TIB; Derated ispta: 720Mw/cm² max; TIS/TIB/TIC: 6.0 Max; MI: 1.9 Max; Derated Isppa: 190W/cm² max	Same

Other differences noted in the "General Comparison" and "Functions Comparison" tables (pages 3-6) include:

Probe Type & Connectors (ID 7): The proposed device has different or additional probe types/frequencies. SE Analysis 1 states these comply with IEC 60601-2-37 and raise no new risks.
Design (ID 9):
- User Interface: Proposed device has a touch panel, predicate has a full keyboard. SE Analysis 2 deems this equivalent based on compliance with IEC 60601-1 and IEC 60601-1-2.
- Image Sector Size: Proposed device: 32 lines to full B (512 lines); Predicate: 32 lines to full B (256 lines). SE Analysis 3 states the proposed device is "better."
- Focal Number: Proposed device: 12 focal zone setting; Predicate: 9 focal zone setting. SE Analysis 3 states the proposed device is "better."
Controls (ID 10):
- PW angle correction: Proposed device: 0 to 80 degree user control; Predicate: 0 to 72 degree user control. SE Analysis 3 states the proposed device is "better."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. The submission explicitly states, "No clinical testing was required" (Section 8, page 2). The device's performance was evaluated through laboratory testing and comparison to an existing predicate device's specifications.
Data Provenance: Not applicable, as no clinical test data was generated for this submission. The comparison relies on the verified specifications of the predicate device (SonoScape SSI-8000, K102642) and the proposed device's compliance with general safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no clinical test set that required ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm for standalone performance evaluation. Its performance is evaluated as an integrated hardware and software ultrasound system under the guidance of a qualified physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth was established as no clinical testing was required. The "truth" for this submission are the established safety and performance specifications and standards for diagnostic ultrasound systems, to which both the proposed and predicate devices are demonstrated to conform.

8. The sample size for the training set

Not applicable. This device is a preprogrammed ultrasound system, not an AI/machine learning model that typically requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/machine learning model.

Summary

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K132527
Page 1 of 10

510(k) Submission

510(k) Summary

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: _

1. Date of submission: August 07, 2013

NOV 1 4 2013

2. 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: S30 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: II

4. Legally Marketed Predicate Device

SonoScape Company Limited, Diagnostic Ultrasound System, Model SSI-8000 has been cleared by FDA through 510(k) No.K102642 (Decision Date - March 04, 2011).

510(k) Summary

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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

7. Testing

Laboratory testing was conducted to verify that the $30 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

510(k) Summary

{2}------------------------------------------------

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.

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

8. Clinical Test:

No clinical testing was required.

9. Comparison Table

The differences between the S30 and the predicate device SSI-8000 in almost every part are listed in the tables below.

ID	Items	Proposed DeviceSonoScape S30	Predicate DeviceSonoScape SSI-8000	Remark
1	IntendedUse	The SonoScape S30 device isa general-purpose ultrasonicimaging instrument intendedfor use by a qualified physicianfor evaluation of Fetal,Abdominal, Pediatric, SmallOrgan (breast, testes, thyroid),Cephalic (neonatal and adult),Trans-rectal, Trans-vaginal,	The device is ageneral-purpose ultrasonicimaging instrument intendedfor use by a qualified physicianfor evaluation of Fetal,Abdominal, Pediatric, SmallOrgan (breast, testes, thyroid),Cephalic (neonatal and adult),Trans-rectal, Trans-vaginal,	Same

Table 1 Intended Use Comparison

510(k) Summary

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510(k) Submission

Trans-esoph (Cardiac),Peripheral Vascular,Musculo-skeletal(Conventional and Superficial),Cardiac (neonatal and adult),Urology and OB/Gyn.	Trans-esoph (Cardiac),Peripheral Vascular,Musculo-skeletal(Conventional and Superficial),Cardiac (neonatal and adult),Urology and OB/Gyn.
---------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 2 General Comparison

ID	ComparisonItems	Proposed DeviceSonoScape S30	Predicate DeviceSonoScape SSI-8000	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
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 MHzL743 Linear Array, 5.0-10.0 MHzL752 Linear Array, 5.0-12.0 MHz10L1 Linear Array, 6.0-12.0 MHzC362 Curved Array, 2.0-6.0 MHzC344 Curved Array, 2.0-5.0 MHzC353 Curved Array, 2.0-6.0 MHzC542 Curved Array, 2.0-7.0 MHzC322 Curved Array, 2.0-6.0 MHzC353 Curved Array, 2.0-6.0	L741 Linear Array, 5.0-10.0 MHzL742 Linear Array, 5.0-12.0 MHzL743 Linear Array, 5.0-10.0 MHzC362 Curved Array, 2.0-6.0 MHzC344 Curved Array, 2.0-5.0 MHz	SEAnalysis1

510(k) Summary

8-4

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510(k) Submission

ID	Comparisonltems	Proposed DeviceSonoScape S30	Predicate DeviceSonoScape SSI-8000	Remark
		MHz
		C611 Micro-curved Array,4.0-8.0 MHzC311 Micro-curved Array,2.0-4.0 MHz	C611 Micro-curved Array.4.0-8.0 MHz
		VC6-2 Curved Array, 2.0-6.0MHz	VC6-2 Curved Array, 2.0-6.0MHz
		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 MHzBCC9-5 Micro-convex Array	EC9-5 Micro-curved Array,5.0-9.0 MHz
		5.0-9.0MHzBCL10-5 Micro-convex Array
		5.0-10.0MHz
		2P1 Phased Array, 2.0-4.0MHz	2P1 Phased Array, 2.0-4.0MHz
		5P1 Phased Array, 4.0-7.0MHz	5P1 Phased Array, 4.0-7.0MHz
		MPTEE Multi-plane Array,4.0-7.0 MHz	MPTEE Multi-plane Array,4.0-7.0 MHz
		MPTEE mini Multi-planeArray, 4.0-7.0 MHz	MPTEE mini Multi-planeArray, 4.0-7.0 MHz
		Multi-port connector connects4 transducers	Multi-port connector connects4 transducers	Same
8	AcousticTrack	TRACK 3	TRACK 3	Same
	Comparison	Proposed Device	Predicate Device
ID	ltems	SonoScape S30	SonoScape SSI-8000	Remark
		Based on an embedded Linux
		operating system.	Based on an embedded Linuxoperating system.	Same
		Based on a 64 channel full	Based on a 64 channel full
		digital beam former.	digital beam former.	SE
		Autocorrelation for color	Autocorrelation for color
		processing and FFT for pulse	processing and FFT for pulse	Same
		and CW Doppler processing.	and CW Doppler processing.
		Supporting Linear, Curve linear	Supporting Linear, Curve linear
		and Phase array probes from 2	and Phase array probes from 2	Same
9	Design	to 15 MHz.	to 15 MHz.
		Cine play back capability	Cine play back capability	Same
		Image file archive	Image file archive	Same
		Software upgrade with USB	Software upgrade with USB	Same
		flash drive.	flash drive.
		Digital Scan Converter	Digital Scan Converter	Same
		800×600	800×600
				SE
		With touch panel	With full keyboard	Analysis2
		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 to	Image sector size: 32 lines to	SE
		full B (512 lines)	full B (256 lines)	Analysis
		Image Sector position: Steering	Image Sector position: Steering	3
		within full maximum	within full maximum	Same
		B orientation flip :L/R key with	B orientation flip :L/R key with
		marking on the screen	marking on the screen	Same
		B Dynamic range control:	B Dynamic range control:
	Operation	preset 14 curves over 140 dB	preset 14 curves over 140 dB	Same
10	Controls	Gray Scale Control: 7 Settings	Gray Scale Control: 7 Settings	Same
		Focal Number: 12 focal zone	Focal Number: 9 focal zone	SE
		setting	setting	Analysis
				3
		B persistence: 0-95%	B persistence: 0-95%	Same
		Image Processing: Smoothing,edge enhancement	Image Processing: Smoothing,edge enhancement	Same
		PW sweeping speed 2,4,6,8	PW sweeping speed 2,4,6,8
		sec over display	sec over display	Same
		PW Wall filter setting: 16	PW Wall filter setting: 16
		settings,25 to 750 HZ	settings 25 to 750 HZ	Same

ID	ComparisonItems	Proposed DeviceSonoScape S30	Predicate DeviceSonoScape SSI-8000	Remark
		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 72degree user control	SEAnalysis3
		PW trace: Peak, Mean	PW trace: Peak, Mean	Same
		PW spectrum dynamicrange:10 preset curve over15-48 dB	PW spectrum dynamicrange:10 preset curve over15-48 dB	Same
		Spectrum baseline shift andinvert	Spectrum baseline shift andinvert	Same
		Color ROI setting: trackball andset key to control size andposition	Color ROI setting: trackball andset key to control size andposition	Same
		Color steering on flatprobe:±20, ±16,0	Color steering on flatprobe:±20, ±16,0	Same
		Color Wall Filter: Color wallfilter with 16 selection, 25-750of PRF	Color Wall Filter: Color wallfilter with 16 selection,25-750of PRF	Same
		Color priority-B priority softmenu	Color priority-B priority softmenu	Same
		Color Packet size: preset perExam, horizontal, vertical, off	Color Packet size: preset perExam, horizontal, vertical, off	Same
		Zoom adjustable	Zoom adjustable	Same
		Freeze control: Toggling freezekey	Freeze control: Toggling freezekey	Same
		Cine control: step, playbackward, play continuously	Cine control: step, playbackward, play continuously	Same
11	OperationMode	B, M, PW, CW, CFM, DPI, TDI,Tissue Harmonic Image3D/4D ModeColor M Mode	B, M, PW, CW, CFM, DPI, TDI,Tissue Harmonic Image3D/4D ModeColor M Mode	Same
12	DisplayModes	Dual B, Quad Display,B and M, B and DopplerB + Color, Dual B(Flow)Triplex mode: B,CFM, andPW/CW, B,DPI, and	Dual B, Quad Display,B and M, B and DopplerB + Color, Dual B(Flow)Triplex mode: B,CFM, andPW/CW, B,DPI, and	Same
ID	ComparisonItems	Proposed DeviceSonoScape S30	Predicate DeviceSonoScape SSI-8000	Remark
		PW/CW,B,THI and Color M,steer MDual B and Color in real timeCompound Imaging,Panoramic Imaging.Trapezoid Imaging.	PW/CW,B,THI and Color MDual B and Color in real timeCompound Imaging,Panoramic Imaging,Trapezoid Imaging.
13	MeasurementItems	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 smallpart package	Same
14	Cine Loop	Automatic review/ manualreview	Automatic review/ manualreview	Same
		Review speed can be adjusted	Review speed can be adjust	Same

510(k) Summary

8-5

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Table 3 Functions Comparison

510(k) Summary

8-6

{6}------------------------------------------------

510(k) Submission

510(k) Summary

{7}------------------------------------------------

510(k) Submission

Table 4 Specifications Comparison

ID	ComparisonItems	Proposed DeviceSonoScape S30	Predicate DeviceSonoScape SSI-8000	Remark
15	PowerSupply	Voltage: 110-127/220-240 VACFrequency: 50/60 HzPower Consumption: 450VA	Voltage: 100/220VACFrequency: 50/60 HzPower Consumption: 330 VA	SEAnalysis4
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	19 inch Widescreen LCD monitor	17 inch LCD color monitor	SEAnalysis5
19	MeasurementAccuracy	Parameter	Value range	Errorrange	Parameter	Valuerange	Errorrange
		Displaydepth	Max 32.9cm; (Probedepend)	$\pm$ 3%	Displaydepth	Max32.9cm;(Probedepend)	$\pm$ 3%	Same
		Distance	0~31.0 cm	$\pm$ 3%	Distance	0~31.0cm	$\pm$ 3%	Same
		Area	Max. ≥855cm²	$\pm$ 7%	Area(Trace)	Max.≥855cm²	$\pm$ 7%	Same
		Angle	10~193°	$\pm$ 3%	Angle	10~193°(Probedepend)	$\pm$ 3%	Same

510(k) Summary

8-8

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510(k) Submission

ID	ComparisonItems		Proposed DeviceSonoScape S30		Predicate DeviceSonoScape SSI-8000	Remark
		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, 8S	±1%	Same
		Heart Rate	8 - 1000beats/sec	±3%	Heart Rate	8 - 1000beats/sec	±3%	Same
		Slope	1300 cm/s	±3%	Slope	1300 cm/s	±3%	Same
		Velocity(PW)	0.04-2940cm/s	Angle ≤60°,≤5%	Velocity(pw)	0.04-2940cm/s	Angles 60°,≤5%	Same
		Velocity(CW)	0.12-3795cm/s	Angle ≤60°,≤5%	Velocity(cw)	0.13-3529cm/s	Angles 60°,≤5%	SEAnalysis
		Velocity(Color)	1-298 cm/s	Angle ≤60°,≤5%	Velocity(color)	2-226cm/s	Angles 60°,≤5%	6
20	AcousticOutput		Track 3:MI,TIS,TIC,TIBDerated ispta: 720Mw/cm²maximum.		Track 3:MI,TIS,TIC,TIBDerated ispta: 720Mw/cm²maximum.TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9 Maximum,orDerated Isppa: 190W/cm² max	Same
			TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9 Maximum,or Derated Isppa: 190W/cm² max

SE Analysis 1:

Probe Type. Compare to the predicate device, the proposed device is with different probe type or frequency, such as L752, 10L1, C353 etc. But no new intended use is added and all of them comply with IEC 60601-2-37. 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 touch panel and the predicate device is with the full keyboard, 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.

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K132527
Page 10 of 10

510(k) Submission

SE Analysis 3:

The proposed device and the predicate device are with different Image sector size/ Focal number/ PW angle correction, but the proposed device is better. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

SE Analysis 4

The Power Supply of the proposed device and the predicate device are 110-127/220-240 VAC, 450VA and 100/220VAC. 330 VA 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 5

The screen size of the proposed is larger than that of the SSI-8000. This difference is considered to have no effect on effectiveness and safety.

SE Analysis 6:

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, 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 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 S30 Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

510(k) Summary

{10}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

November 14, 2013

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

Re: K132527

Trade/Device Name: S30 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, and ITX Dated: August 7, 2013 Received: August 19, 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 to eoniners 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 S30 Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1 Phase Array C311 Micro-curved Array EC9-5 Micro-curved Array C344 Curved Array C362 Curved Array L741 Linear Array L752 Linear Array MPTEE mini Multi-plane Array

5P1 Phase Array 6VI Micro-curved Array BCC9-5 Micro-curved Array C353 Curved Array C322 Curved Array L742 Linear Array 10L1 Linear Array

C611 Micro-curved Array 6V3 Micro-curved Array BCL10-5 Biplane Array C542 Curved Array VC6-2 Curved Array L743 Linear Array MPTEE Multi-plane Array

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

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/ResourcesforYou/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/McdjcalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of 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,

Sm.h.7)

ிர

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

Enclosure

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

Indications for Use

510(k) Number: K132527

S30 Digital Color Doppler Ultrasound System Device Name:

Indications for Use: The SonoScape S30 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. Trans-esoph (Cardiac), Peripheral Vascular, Cardiac Musculo-skeletal (Conventional and Superficial), (neonatal and adult), Urology and OB/Gyn.
. Over-The-Counter Use _ AND/OR Prescription Use ____________X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(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)

$\sin^{-1}(x)$

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

510(k) __ K132527

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

SonoScape S30 System:

Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging System

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

Clinical Application		Mode of Operation
General(TRACK 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
	Other (Urology)	N	N	N		N	N	Note 1	Notes 2, 4
	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)	N	N	N	N	N	N	Note 1	Notes 2,3,4
	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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging 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

7-2 .

Page 002 of 024

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

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	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)
	Other (Urology)
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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

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

Transducer: 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
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)
	Other (Urology)
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)

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

Note 1: Other Combined includes: BIM; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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) __ .

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

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	P	P	P		P	P	Note 1	Notes 2.4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	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	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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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

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

Transducer: C311 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
	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
	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/THl (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

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

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
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)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2.4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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

Note 1: Other Combined includes: BIM; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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) .

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

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	Color Doppler	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)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

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

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)
	Other (Urology)	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: P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

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

Transducer: BCC9-5 Micro-curved Array

Diagnostic Uitrasound 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)
	Other (Urology)	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; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD: B/THI (The feature does not use contrast agents); M/Color M: B/Color Doppler: B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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) ___

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

Transducer: BCL10-5 Biplane Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General(TRACK 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)
	Other (Urology)	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; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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

7-11

. . .

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

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	Spocific					Color	Power	Other*	Other*
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)	Combined	Specify
ONLY)							Doppler
Ophthalmic	Ophthalmic
Felal	Fetal	P	P	P		P	P	Note 1	Notes 2.4
Imaging&	Abdominal	P	P	P		P	P	Note 1	Noles 2.4
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
l	(Conventional)
l	Musculo-skeletal
	(Superficial)
:	Intravascular
	Other (Ob/GYN)	ర్	P	్రీ		p	P	Note 1	Notes 2.4
	Other (Urology)	P	P	P		p	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
I 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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppier/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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) _______________________________________________________________________________________________________________________________________________________________________

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

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
	Other (Urology)	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)

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

Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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) _______________________________________________________________________________________________________________________________________________________________________

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

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)
	Other (Urology)	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; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH! (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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

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

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
General	Specific					Color	Power .	Other"	Other
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)	Combined	Specify
ONLY)							Doppler
Ophthalmic	Ophthalmic
Felal	Fetal	P	ర్	P		P	പ്ര	Note 1	Notes 2.4
Imaging&	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
- AA = A May	Neonatal Cephalic
l	Adult Cephalic
י	Trans-rectal
:	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
	Other (Urology)	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
Vessel	Other (specify)

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

Note 1: Other Combined includes: BIM: B/PWD: B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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) ___

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

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
	Other (Urology)
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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

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

Transducer: VC6-2 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2.4.5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
	Other (Urology)
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: BIM; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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) __

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

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)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
Vessel	Other (specify)

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

Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

7-18

Page 018 of 024

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

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						Other*
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined	Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2.4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2.4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2.4
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: BIM; B/PWD; B/THI (The feature does not use contrast agents);

M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

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

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)	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)
	Other (Urology)
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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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) __________

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

Transducer: L752 Linear Array

Diagnostic Ultrasound Transducer

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)
	Other (Urology)
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:

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents);

M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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

Note 3: TDI

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

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)
	Other (Urology)
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: BIM; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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

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

Transducer: MPTEE Multi-plane Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General	Specific					Color	Power	Other*	Other*
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)	Combined	Specify
ONLY)							Doppler
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&	Abdominal
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
	(Conventional)
	Musculo-skeleta!
	(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)	P	P	P		P	P	Note 1	Notes 2,3.4
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
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 (The feature does not use contrast agents), M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

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) _______________________________________________________________________________________________________________________________________________________________________

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

Transducer: MPTEE mini Multi-plane Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General	Specific					Color	Power	Other*	Other*
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)Doppler	Combined	Specify
ONLY)
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&Other	Abdominal
	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)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)	P	P	P		P	P	Note 1	Notes 2.3.4
	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 (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 4: 3D 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) ___

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.