S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

• K Number: K132768
• Device Name: S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
• Manufacturer: SONOSCAPE COMPANY LIMITED
• Date Cleared: 2013-10-04 ( 30 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The SonoScape S8 Exp device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Description

The SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

Predicate Devices

K131088

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and image processing techniques (smoothing, edge enhancement) but does not mention AI, ML, or any related concepts. The performance studies focus on laboratory testing and safety standards, not AI/ML performance metrics.

Therapeutic

No
The device is described as a "clinical diagnostic imaging system" and its basic function is to "acquire ultrasound data and display the image". There is no mention of treating or monitoring a disease or condition.

Diagnostic

Yes

Explanation: The "Device Description" explicitly states, "This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system." Additionally, the "Intended Use" section mentions its use for "evaluation" of various body parts and conditions, which is indicative of a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and mentions hardware components like "imaging transducers." It also details performance studies related to acoustic output and electrical safety, which are characteristic of hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, the SonoScape S8 Exp device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use clearly states that the device is a general-purpose ultrasonic imaging instrument used by a qualified physician for the evaluation of various anatomical sites. This involves imaging the internal structures of the body.
• Device Description: The description details an ultrasound system that acquires ultrasound data and displays images in various modes. This is consistent with in-vivo imaging, not testing samples outside the body.
• Input Imaging Modality: The input modality is Ultrasound, which is used for imaging within the body.
• Anatomical Site: The listed anatomical sites are all parts of the human body.
• No mention of analyzing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample outside of the body.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a physiological or pathological state. The SonoScape S8 Exp is an imaging device used to visualize structures within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoScape S8 Exp device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Product codes

IYN, IYO, ITX

Device Description

The SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Indicated Patient Age Range

Neonatal and adult for Cephalic and Cardiac. Other indications do not specify age range.

Intended User / Care Setting

Qualified physician. Care setting not specified.

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

Not Found

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

Not Found

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

No clinical testing was required. Laboratory testing was conducted to verify that the S8 Exp system with added transducer met all design specification and was substantially equivalent to the Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" and "NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment".

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

Not Found

Predicate Device(s)

K131088

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

510(k) Submission

510(k) Summary

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

August 30, 2013

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

Name of Sponsor:	SonoScape Company Limited
Address:	Yizhe Building, Yuquan Road, Nanshan, Shenzhen
518051, P.R.China
Contact Name:	Toki Wu
Telephone No.:	[phone]
Fax No.:	[phone]
Email Address:	[e-mail]/[e-mail]

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

Trade Name:	S8 Exp Portable Digital Color Doppler Ultrasound System
Common Name:	Diagnostic Ultrasound System and Transducers
Classification:	-
	21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System	Product code: IYN
	21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System	Product code: IYO
	21 CFR892.1570 Diagnostic Ultrasonic Transducer	Product code: ITX
Classification Panel:	Radiology
Device Class:	II

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

The identified predicates within this submission are as follows: SonoScape Company Limited, Portable Digital Color Doppler Ultrasound System, Model S9 has been cleared by FDA through 510(k) No.K131088 (May 24, 2013).

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

The SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and

510(k) Summary

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confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

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

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

The SonoScape S8 Exp device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

7. Testing

Laboratory testing was conducted to verify that the S8 Exp system with added transducer met all design specification and was substantially equivalent to the Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" and "NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment".

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

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

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

2

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

| ID | Items | Proposed Device
SonoScape S8 Exp | Predicate Device
SonoScape S9 | Remark |
|----|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 1 | Intended
Use | The SonoScape S8 Exp device
is a general-purpose ultrasonic
imaging instrument intended for
use by a qualified physician for
evaluation of Fetal, Abdominal,
Pediatric, Small Organ (breast,
testes, thyroid),
Cephalic(neonatal and adult),
Trans-rectal, Trans-vaginal,
Peripheral Vascular,
Musculo-skeletal (Conventional
and Superficial), Cardiac
(neonatal and adult), OB/Gyn
and Urology. | The SonoScape S9 device is a
general-purpose ultrasonic
imaging instrument intended for
use by a qualified physician for
evaluation of Fetal, Abdominal,
Pediatric, Small Organ (breast,
testes, thyroid),
Cephalic(neonatal and adult),
Trans-rectal, Trans-vaginal,
Peripheral Vascular,
Musculo-skeletal (Conventional
and Superficial), Cardiac
(neonatal and adult), OB/Gyn
and Urology. | Same |

Table 1 Intended Use Comparison

Table 2 General Comparison

| ID | Comparison
Items | Proposed Device
SonoScape S8 Exp | Predicate Device
SonoScape S9 | Remark |
|----|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 2 | Classification
Name | Ultrasonic Pulsed Doppler
Imaging System
Ultrasonic Pulsed Echo
Imaging System
Diagnostic Ultrasound
Transducer | Ultrasonic Pulsed Doppler
Imaging System
Ultrasonic Pulsed Echo
Imaging System
Diagnostic Ultrasound
Transducer | 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 |
| ID | Comparison Items | Proposed Device SonoScape S8 Exp | Predicate Device SonoScape S9 | Remark |
| 5 | Panel | Radiology | Radiology | Same |
| 6 | Class | II | II | Same |
| 7 | Probe Type & Connectors | L741 Linear Array, 5.0-10.0 MHz
L742 Linear Array, 5.0-12.0 MHz
L752 Linear Array, 5.0-12.0 MHz
L743 Linear Array, 5.0-10.0 MHz
10L1 Linear Array, 6.0-12.0 MHz
C611 Micro-curved Array,
4.0-8.0 MHz
C311 Micro-curved Array,
2.0-4.0 MHz
C344 Curved Array, 2.0-5.0 MHz
C322 Curved Array, 2.0-6.0 MHz
C353 Curved Array, 2.0-6.0 MHz
C362 Curved Array, 2.0-6.0 MHz
C354 Curved Array, 2.0-6.0 MHz
C542 Curved Array, 4.0-7.0 MHz
VC6-2 Curved Array,
2.0-6.0 MHz | L741 Linear Array, 5.0-10.0 MHz
L742 Linear Array, 5.0-12.0 MHz
L752 Linear Array, 5.0-12.0 MHz
/ | SE
Analysis
1 |
| | | C344 Curved Array, 2.0-5.0 MHz | | |
| | | C322 Curved Array, 2.0-6.0 MHz | | |
| | | C353 Curved Array, 2.0-6.0 MHz | | |
| | | VC6-2 Curved Array,
2.0-6.0 MHz | | |
| | | 6V1 Micro-curved Array,
4.0-8.0 MHz | 6V1 Micro-curved Array,
4.0-8.0 MHz | |
| | | 6V3 Micro-curved Array,
5.0-9.0 MHz | 6V3 Micro-curved Array,
5.0-9.0 MHz | |
| | | EC9-5 Micro-curved Array,
5.0-9.0 MHz | | |
| | | BCC9-5 Micro-convex Array.
5.0-9.0MHz | | |
| | | BCL10-5 Micro-convex Array,
5.0-10.0MHz | | |
| | | 2P2 Phased Array, 1.0-5.0 MHz | 2P2 Phased Array, 1.0-5.0 MHz | |
| | | 3P1 Phased Array, 1.0-5.0 MHz | 3P1 Phased Array, 1.0-5.0 MHz | |
| | | 5P2 Phased Array, 3.0-8.0 MHz | 5P2 Phased Array, 3.0-8.0 MHz | |
| | | 8P1 Phased Array, 4.0-12.0 MHz | 8P1 Phased Array, 4.0-12.0 MHz | |
| | | 2P1 Phased Array, 2.0-4.0 MHz
5P1 Phased Array, 4.0-7.0 MHz | | |
| | | Multi-port connector connects 2 transducers | Multi-port connector connects 2 transducers | |
| 8 | Acoustic Track | TRACK 3 | TRACK 3 | Same |
| ID | Comparison
Items | Proposed Device
SonoScape S8 Exp | Predicate Device
SonoScape S9 | Remark |
| | | Based on an embedded Linux
operating system. | Based on an embedded
Linux operating system. | Same |
| | | Based on a 128 channel full
digital beam former. | Based on a 128 channel full
digital beam former. | Same |
| | | Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing. | Autocorrelation for color
processing and FFT for
pulse and CW Doppler
processing. | Same |
| 9 | Design | Supporting Linear, Curve
linear and Phase array probes
from 2 to 15 MHz. | Supporting Linear, Curve
linear and Phase array
probes from 2 to 15 MHz. | Same |
| | | Cine play back capability | Cine play back capability | Same |
| | | Image file archive | Image file archive | Same |
| | | Software upgrade with USB
flash drive. | Software upgrade with USB
flash drive. | Same |
| | | Digital Scan Converter
800×600 | Digital Scan Converter
800×600 | Same |
| | | With full keyboard panel | With touch-screen panel | SE
Analysis
2 |
| | | 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
full B (256 lines) | Image sector size: 32 lines
to full B (256 lines) | Same |
| | | Image Sector position:
Steering within full maximum | Image Sector position:
Steering within full maximum | Same |
| | Operation
Controls | B orientation flip :L/R key with
marking on the screen | B orientation flip :L/R key
with marking on the screen | Same |
| 10 | | B Dynamic range control:
preset 14 curves over 140 dB | B Dynamic range control:
preset 14 curves over 140 dB | Same |
| | | Gray Scale Control: 7 Settings | Gray Scale Control: 7
Settings | Same |
| | | Focal Number: 12 focal zone
setting | Focal Number: 12 focal zone
setting | Same |
| | | 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 | Same |

510(k) Summary

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510(k) Summary

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Table 3 Functions Comparison

510(k) Summary

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

510(k) Summary

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| ID | Comparison
Items | Proposed Device
SonoScape S8 Exp | Predicate Device
SonoScape S9 | Remark |
|----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | 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. | 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. | |
| 13 | Measurement Items | Distance; area; circumference;
calipers; volume, velocity, HR,
PI, RI. Cardiac. OB/GYN,
Urology, Vascular and small
part package | Distance; area;
circumference; calipers;
volume, velocity, HR, PI, RI.
Cardiac: OB/GYN, Urology.
Vascular and small part
package | Same |
| 14 | Cine Loop | Automatic review/ manual
review
Review speed can be adjusted | Automatic review/ manual
review
Review speed can be
adjusted | Same |

Table 4 Specifications Comparison

| ID | Comparison
Items | Proposed Device
SonoScape S8 Exp | Predicate Device
SonoScape S9 | Remark | | |
|----|-------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------|
| 15 | Power
Supply | Voltage: 110-240 VAC
Frequency: 50/60 Hz
Power Consumption: 110-240V AC, 2.7-1.2A | Voltage: 110-240 VAC
Frequency: 50/60 Hz
Power Consumption: 110-240V AC, 2.7-1.2A | Same | | |
| | | 16 | Operating
Condition | Temperature: 1040°C
Relative humidity: 3075%
Air pressure: 700hPa 1060hPa | Temperature: 1040°C
Relative humidity: 3075%
Air pressure: 700hPa 1060hPa | Same |
| | | 17 | Storage
Condition | Temperature: -2055°C
Relative humidity: 2090%
Air pressure: 700hPa 1060hPa | Temperature: -2055°C
Relative humidity: 20~90%
Air pressure: 700hPa ~1060hPa | Same |
| 18 | Screen Size | 15 inch Widescreen LCD monitor | 15 inch Widescreen LCD monitor | Same | | |
| 19 | Measurement
Accuracy | Parameter: Display depth
Value range: Max 32.9 cm; (Probe depend)
Error range: ±3% | Parameter: Display depth
Value range: Max 32.9 cm; (Probe depend)
Error range: ±3% | Same | | |

510(k) Summary

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SonoScape Company Limited

510(k) Submission

| ID | Comparison
Items | | Proposed Device
SonoScape S8 Exp | | Predicate Device
SonoScape S9 | Remark | | |
|----|---------------------|----------------------------------------------------------------------------------|-------------------------------------|-----------------|----------------------------------------------------------------------------------|------------------|-----------------|------|
| | | Distance | 031.0 cm | ±3% | Distance | 031.0 cm | ±3% | Same |
| | | Area | Max. ≥855 cm² | ±7% | Area | Max. ≥855 cm² | ±7% | Same |
| | | Angle | 10193° | ±3% | Angle | 10193° | ±3% | Same |
| | | Circumference | 200 cm | ±3% | Circumference | 200 cm | ±3% | Same |
| | | Volume | Max. 25000 cm³ | ±10% | Volume | Max. 25000 cm³ | ±10% | Same |
| | | M-Mode time | 2,4,6,8 S | ±1% | M-Mode time | 2,4,6,8 S | ±1% | Same |
| | | Heart Rate | 81000 beats/sec | ±3% | Heart Rate | 81000 beats/sec | ±3% | Same |
| | | Slope | 1300 cm/s | ±3% | Slope | 1300 cm/s | ±3% | Same |
| | | Velocity (PW) | 0.04-2940 cm/s | Angle ≤60°, ≤5% | Velocity (PW) | 0.04-2940 cm/s | Angle ≤60°, ≤5% | Same |
| | | Velocity (CW) | 0.12-3795 cm/s | Angle ≤60°, ≤5% | Velocity (CW) | 0.12-3795 cm/s | Angle ≤60°, ≤5% | Same |
| | | Velocity (Color) | 1-298 cm/s | Angle ≤60°, ≤5% | Velocity (Color) | 1-298 cm/s | Angle ≤60°, ≤5% | Same |
| 20 | Acoustic Output | Track 3:MI, TIS, TIC, TIB
Derated ispta: 720Mw/cm² maximum. | | | Track 3: MI, TIS, TIC, TIB
Derated ispta: 720Mw/cm² maximum. | | | Same |
| | | TIS/TIB/TIC: 6.0 Maximum,
Mechanical Index: 1.9
Maximum, or Derated Isppa: | | | TIS/TIB/TIC: 6.0 Maximum,
Mechanical Index: 1.9
Maximum, or Derated Isppa: | | | |
| | | 190W/cm² max | | | 190W/cm² max | | | |

Table 5 Safety Comparison

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

510(k) Summary

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K132768
Page 9 of 9

510(k) Submission

SE Analysis 1:

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

SE Analysis 2:

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

Discussion of Substantially Equivalent

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

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

10 Substantially Equivalent Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S8 Exp Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

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

October 4, 2013

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

Re: K132768

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

Dear Ms. Wu:

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

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

Transducer Model Number

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

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

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

10

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

Sincerely yours.

for

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

Enclosure

11

Indications for Use

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

Indications for Use: The SonoScape S8 Exp device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

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

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

AND/OR

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

$m.h.7).

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

K132768 510(k) _

12

System: SonoScape S8 Exp

Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging System

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

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	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
Imaging&
Other	Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	N	N	N		N	N	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4,5
	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Other (specify)

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

13

Transducer: 2P1 Phase Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CW
D	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
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)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

Indications for Use

14

Transducer: 2P2 Phase Array

Diagnostic Ultrasound Transducer

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

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

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) .

15

Transducer: 3P1 Phase Array

Diagnostic Ultrasound Transducer

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

16

Transducer: 5P1 Phase Array

Diagnostic Ultrasound Transducer

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

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

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

17

Transducer: 5P2 Phase Array

Diagnostic Ultrasound Transducer

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

18

Transducer: 8P1 Phase Array

Diagnostic Ultrasound Transducer

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

19

Transducer: C611 Micro-curved Array

Diagnostic Ultrasound Transducer

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

20

Transducer: C311 Micro-curved Array

SonoScape Company Limited

Diagnostic Ultrasound Transducer

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

21

Transducer: 6V1 Micro-curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
	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)
Peripheral
Vessel	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 5: 4D Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

22

Transducer: 6V3 Micro-curved Array

Diagnostic Ultrasound Transducer

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

Indications for Use

23

Transducer: EC9-5 Micro-curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application	Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

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

• Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 4: 3D Note 5: 4D Note 3: TDI
  Note 6: Small Organ: breast, thyroid, testes

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

510(k)

Indications for Use

24

Transducer: BCC9-5 Micro-curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult .
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

Indications for Use

25

Transducer: BCL10-5 Biplane Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

26

Transducer: C344 Curved Array

Diagnostic Ultrasound Transducer

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

Indications for Use

27

Transducer: C353 Curved Array

Diagnostic Ultrasound Transducer

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

28

Transducer: C354 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	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 Doppier/PWD

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

Indications for Use

29

Transducer: C542 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

Indications for Use

30

Transducer: C362 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

Indications for Use

31

Transducer: C322 Curved Array

Diagnostic Ultrasound Transducer

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

. 510(k) _

32

Transducer: VC6-2 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other
Combined	Other
Specify
Ophthalmic	Ophthalmic
Fetal	Fetal	p	P	P		P	P	Note 1	Notes 2,4,5
Imaging &	Abdominal	P	P	p		P	P	Note 1	Notes 2,4,5
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2.4.5
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

33

Transducer: L741 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General	Specific	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
(TRACK 1
ONLY)	(TRACKS 1 & 3)
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	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)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Other (specify)

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

Doppler/PWD; B/Power Doppler/PWD

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

34

Transducer: L742 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation								Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	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)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Other (specify)

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) __

35

Transducer: L743 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
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)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Other (specify)

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

Doppler/PWD; B/Power Doppler/PWD

.

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

36

Diagnostic Ultrasound Indications for Use Form

Transducer: L752 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	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)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Other (specify)

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

Indications for Use

37

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

Transducer: 10L1 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
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)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Other (specify)

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

• Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDi Note 4: 3D Note 5: 4D
  Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

.

Indications for Use