DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

• K Number: K131213
• Device Name: DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
• Manufacturer: SONOSCAPE COMPANY LIMITED
• Date Cleared: 2013-06-21 ( 53 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The SonoScape S40 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Description

The SonoScape S40 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

Predicate Devices

K112602

Reference Devices

K112602

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard digital ultrasound system with image processing features like smoothing and edge enhancement, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on laboratory testing and safety standards, not on the evaluation of AI/ML performance metrics.

Therapeutic

No
The device is described as an "ultrasonic imaging instrument" and a "diagnostic ultrasound system" intended for "clinical diagnostic imaging applications," which means it is used for diagnosis, not therapy.

Diagnostic

Yes

The "Device Description" explicitly states, "This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system." It also mentions "clinical diagnostic imaging applications" and "enhance the diagnostic utility and confidence provided by the system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and mentions "all digital architecture" and "imaging transducers," indicating it includes hardware components beyond just software. The performance studies also mention testing the "S40 system with added transducer" and conforming to "thermal, mechanical and electrical safety," further confirming the presence of hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• SonoScape S40 Function: The SonoScape S40 is an ultrasound imaging system. It uses sound waves to create images of internal body structures. It does not analyze specimens taken from the body.
• Intended Use: The intended use clearly states it's for "evaluation of Fetal, Abdominal, Pediatric, Small Organ... Cardiac... OB/Gyn and Urology," which are all applications of in-vivo imaging, not in-vitro analysis.
• Device Description: The description focuses on the ultrasound technology, image processing, and different imaging modes (B-Mode, M-Mode, Doppler, 3D/4D), all of which are characteristic of an ultrasound machine.
• Lack of Specimen Analysis: There is no mention of analyzing any type of biological specimen.

Therefore, based on the provided information, the SonoScape S40 is a diagnostic imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoScape S40 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Product codes

IYN, IYO, ITX

Device Description

The SonoScape S40 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

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

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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System

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), Pediatric

Intended User / Care Setting

Qualified physician

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

Laboratory testing was conducted to verify that the S40 system with added transducer met all design specification and was substantially equivalent to the Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment". No clinical testing was required.

Key Metrics

Not Found

Predicate Device(s)

K112602

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

JUN 2 1 2013

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

The assigned 510(k) number: K131213

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

SonoScape Company Limited Address: Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China Tel: [phone] Fax: [phone] Contact Person: Toki Wu E-mail:[e-mail]/[e-mail]

3. Proposed Device Identification

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

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

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

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Classification Panel: Radiology

Device Class: Il

4. Legally Marketed Predicate Device

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

1

5. Device Description

The SonoScape S40 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

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

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

6. Intended Use Statement

The SonoScape S40 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Transducer Information is shown in the table 1.

| No. | Probe | Type | Frequency
Range | Intended Use |
|-----|-------|-----------------------|--------------------|-------------------------------|
| 1 | C344 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 2 | C353 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 3 | C322 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 4 | VC6-2 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 5 | 6V1 | Micro-curved
Array | 4.0-8.0 MHz | Trans-rectal
Trans-vaginal |
| 6 | 6V3 | Micro-curved | 5.0-9.0 MHz | Trans-rectal |

Table 1 Transducer Information

510(k) Summary

2

510(k) Submission

| No. | Probe | Type | Frequency
Range | Intended Use |
|-----|-------|--------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | | Array | | Trans-vaginal |
| 7 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (breast, thyroid, testes)
Musculo-skeletal (Conventional)
Peripheral vessel |
| 8 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (breast, thyroid, testes)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel |
| 9 | L752 | Linear Array | 5.0-12.0 MHz | Small Organ (breast, thyroid, testes)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel |
| 10 | 2P2 | Phase Array | 1.0-5.0 MHz | Abdominal
Cephalic(neonatal and adult)
Cardiac (neonatal and adult) |
| 11 | 3P1 | Phase Array | 1.0-5.0 MHz | Abdominal
Cephalic(neonatal and adult)
Cardiac (neonatal and adult) |
| 12 | 5P2 | Phase Array | 3.0-8.0 MHz | Pediatric
Neonatal Cephalic
Cardiac Pediatric |
| 13 | 8P1 | Phase Array | 4.0-12.0 MHz | Pediatric
Neonatal Cephalic
Cardiac Pediatric |

7. Testing

Laboratory testing was conducted to verify that the S40 system with added transducer met all design specification and was substantially equivalent to the Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment".

510(k) Summary

3

| Standards

No.	Standards Title	Version	Date
IEC 60601-1	Medical Electrical Equipment - Part1.
General Requirements for Safety	1988+A1:
1991+A2:
1995	10/31/2005
IEC
60601-1-2	Medical Electrical Equipment, Part 1-2:
General Requirements for Safety -
Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests	2007	03/01/2007
IEC
60601-2-37	Medical Electrical Equipment, Part 2-37:
Particular Requirements for the Safety of
Ultrasonic Medical Diagnostic and
Monitoring Equipment	2007	08/01/2007
NEMA UD 2	Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Version 3	2004	01/01/2004
(R 2009)
NEMA UD3	Standard for Real-Time Display of Thermal
and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment	2004	01/01/2004
(R 2009)
ISO 10993-5	Biological evaluation of medical devices -
Part 5: Tests for In Vitro cytotoxicity	1999	05/15/1999
ISO
10993-10	Biological evaluation of medical devices -
Part 10: Tests for irritation and delayed-type
hypersensitivity	2002	09/01/2002

Tab 2 Applicable Safety Standards

8. Clinical Test:

No clinical testing was required.

9. Comparison Table

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

4

| ID | Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | Remark |
|----|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 1 | Intended Use | The 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),
Urology and OB/Gyn. | The 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 3 Intended Use Comparison

·

Table 4 General Comparison

| ID | Comparison Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | 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 |
| 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 | L741 Linear Array, 5.0-10.0 MHz
L742 Linear Array, 5.0-12.0 MHz
L743 Linear Array, 5.0-10.0 MHz | SE
Analysis
1 |

510(k) Summary

8-5

5

510(k) Submission

| ID | Comparison
Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | Remark |
|----|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | C344 Curved Array, 2.0-5.0
MHz
C322 Curved Array, 2.0-6.0
MHz
C353 Curved Array, 2.0-6.0
MHz | C344 Curved Array, 2.0-5.0
MHz
C362 Curved Array, 2.0-6.0
MHz | |
| | | | C611 Micro-curved Array,
4.0-8.0 MHz | |
| | | VC6-2 Curved Array, 2.0-6.0
MHz
6V1 Micro-curved Array,
4.0-8.0 MHz
6V3 Micro-curved Array,
5.0-9.0 MHz | VC6-2 Curved Array, 2.0-6.0
MHz
6V1 Micro-curved Array,
4.0-8.0 MHz
6V3 Micro-curved Array,
5.0-9.0 MHz
EC9-5 Micro-curved Array,
5.0-9.0 MHz | |
| | | 2P2 Phased Array, 1.0-5.0
MHz
3P1 Phased Array, 1.0-5.0
MHz
5P2 Phased Array, 3.0-8.0
MHz
8P1 Phased Array, 4.0-12.0
MHz
Multi-port connector connects | 2P1 Phased Array, 2.0-4.0
MHz
5P1 Phased Array, 4.0-7.0
MHz
Multi-port connector connects | |
| | | 4 transducers | 2 transducers | |
| 8 | Acoustic
Track | TRACK 3 | TRACK 3 | Same |

Table 5 Functions Comparison

| ID | Comparison
Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | Remark |
|----|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 9 | | Based on an embedded Linux
operating system. | Based on an embedded Linux
operating system. | Same |
| | Design | Based on a 128 channel full
digital beam former. | Based on a 64 channel full
digital beam former. | SE
Analysis
2 |
| | | Autocorrelation for color
processing and FFT for pulse | Autocorrelation for color
processing and FFT for pulse | Same |
| ID | Comparison
Items | Proposed Device
SonoScape S40
and CW Doppler processing. | Predicate Device
SonoScape S6
and CW Doppler processing. | Remark |
| | | 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 touch panel | With full keyboard | SE
Analysis
3 |
| | | 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 (512 lines) | Image sector size: 32 lines to
full B (256 lines) | SE
Analysis
4 |
| | | Image Sector position: Steering
within full maximum | Image Sector position: Steering
within full maximum | Same |
| | | B orientation flip :L/R key with
marking on the screen | B orientation flip :L/R key with
marking on the screen | Same |
| | | B Dynamic range control:
preset 14 curves over 140 dB | B Dynamic range control:
preset 14 curves over 140 dB | Same |
| | | Gray Scale Control: 7 Settings | Gray Scale Control: 7 Settings | Same |
| | | Focal Number: 12 focal zone
setting | Focal Number: 12 focal zone
setting | Same |
| 10 | Operation
Controls | 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
sec over display | PW sweeping speed 2,4,6,8
sec over display | Same |
| | | PW Wall filter setting:16
settings,25 to 750 HZ | PW Wall filter setting:16
settings,25 to 750 HZ | Same |
| | | PW sample volume:0.5 to
20mm | PW sample volume:0.5 to
20mm | Same |
| | | PW/B update: with UPDATE
key | PW/B update: with UPDATE
key | Same |
| | | PW cursor steering: Steer soft
key | PW cursor steering: Steer soft
key | Same |
| | | PW angle correction:0 to 80
degree user control | PW angle correction:0 to 80
degree user control | Same |
| ID | Comparison Items | Proposed Device SonoScape S40 | Predicate Device SonoScape S6 | Remark |
| | | PW spectrum dynamic range:10 preset curve over 15-48 dB | PW spectrum dynamic range:10 preset curve over 15-48 dB | Same |
| | | Spectrum baseline shift and invert | Spectrum baseline shift and invert | Same |
| | | Color ROI setting: trackball and set key to control size and position | Color ROI setting: trackball and set key to control size and position | Same |
| | | Color steering on flat probe: $\pm$ 20, $\pm$ 16,0 | Color steering on flat probe: $\pm$ 20, $\pm$ 16,0 | Same |
| | | Color Wall Filter: Color wall filter with 16 selection, 25-750 of PRF | Color Wall Filter: Color wall filter with 16 selection, 25-750 of PRF | Same |
| | | Color priority-B priority soft menu | Color priority-B priority soft menu | Same |
| | | Color Packet size: preset per Exam, horizontal, vertical, off | Color Packet size: preset per Exam, horizontal, vertical, off | Same |
| | | Zoom adjustable | Zoom adjustable | Same |
| | | Freeze control: Toggling freeze key | Freeze control: Toggling freeze key | Same |
| | | Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Same |
| 11 | Operation Mode | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image 3D/4D Mode Color M Mode | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image 3D/4D Mode Color M Mode | Same |
| 12 | Display Modes | Dual B, Quad Display, B and M, B and Doppler B + Color, Dual B(Flow) Triplex mode: B,CFM, and PW/CW; B,DPI, and PW/CW;B,THI and Color M, steer M Dual B and Color in real time Compound Imaging, Panoramic Imaging, Trapezoid Imaging. | Dual B, Quad Display, B and M, B and Doppler B + Color, Dual B(Flow) Triplex mode: B,CFM, and PW/CW; B,DPI, and PW/CW;B,THI and Color M, steer M Dual B and Color in real time Compound Imaging, Panoramic Imaging, Trapezoid Imaging. | Same |
| 13 | Measurement Items | Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small | Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small | Same |
| ID | Comparison
Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | Remark |
| | | part package | part package | |
| 14 | Cine Loop | Automatic review/ manual
review | Automatic review/ manual
review | Same |
| | | Review speed can be adjusted | Review speed can be adjusted | Same |

510(k) Summary

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510(k) Submission

510(k) Summary

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510(k) Submission .

510(k) Summary

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510(k) Submission

Table 6 Specifications Comparison

.

| ID | Comparison
Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | Remark | | | | |
|----|-------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------|------------------|--------------------------------|----------------|------|
| 15 | Power
Supply | Voltage: 110-127/220-240 VAC
Frequency: 50/60 Hz
Power Consumption: 450VA | Voltage: 110-240 VAC
Frequency: 50/60 Hz
Power Consumption: 110-240V AC, 2.7-1.2A | SE
Analysis
5 | | | | |
| 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: 2090%
Air pressure: 700hPa 1060hPa | Same | | | | |
| 18 | Screen Size | 18.5 inch Widescreen LCD
monitor | 15 inch Widescreen LCD monitor | SE
Analysis
6 | | | | |
| 19 | Measurement
Accuracy | Parameter | Value range | Error
range | Parameter | Value range | Error
range | |
| | | Display
depth | Max 32.9 cm; (Probe
depend) | ±3% | Display
depth | Max 32.9 cm; (Probe
depend) | ±3% | Same |
| | | 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 | 8 ~ 1000
beats/sec | ±3% | Heart
Rate | 8 ~ 1000
beats/sec | ±3% | Same |
| | Slope | 1300 cm/s | ±3% | Slope | 1300 cm/s | ±3% | Same | |

510(k) Summary

9

510(k) Submission

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

Table 7 Safety Comparison

| ID | Comparison Items | Proposed Device
SonoScape S40 | Predicate Device
SonoScape S6 | Remark |
|----|---------------------------------|-------------------------------------|-------------------------------------|--------|
| 21 | Electrical Safety | -IEC 60601-1 | -IEC 60601-1 | Same |
| 22 | EMC | -IEC 60601-1-2 | -IEC 60601-1-2 | Same |
| 23 | Performance | -IEC 60601-2-37 | -IEC 60601-2-37 | Same |
| 24 | Biocompatibility | -ISO 10993-5,
-ISO 10993-10 | -ISO 10993-5,
-ISO 10993-10 | Same |
| 25 | Level of Concern
Of Software | Moderate level of
concern system | Moderate level of
concern system | Same |

SE Analysis 1:

Probe Type & Connectors, Compare to the predicate device, the proposed device is with different probe type or frequency, such as L752, C353 etc. But no new intended use is added and all of them comply with IEC 60601-2-37; And the proposed device has 4 probe connection ports and the predicate device has 2 probe connection ports, but both of them comply with IEC 60601-1 and IEC 60601-1-2, therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

10

SE Analysis 2: ·

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

SE Analysis 3:

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

SE Analysis 4:

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

SE Analysis 5

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

SE Analysis 6

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

SE Analysis 7:

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

Discussion of Substantially Equivalent

The subject device has same intended use, similar product design, and same performance effectiveness, performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design

8-11

11

K131213
Page 12 of 12

510(k) Submission

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

10. Substantially Equivalent Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S40 Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

510(k) Summary

12

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

June 21, 2013

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

Re: K131213

Trade/Device Name: S40 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYN, IYO, and ITX Dated: April 26, 2013 Received: May 2, 2013

Dear Ms. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the S40 Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

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

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

13

Page 2 - Ms. Toki Wu

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050;

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

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

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

If you have any questions regarding the content of this letter, please contact Shing Chun Benny Lam, Ph.D. at [phone].

Sincerely yours,

for

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

Enclosures

14

Indications for Use

510(k) Number:	K131213
Device Name:	S40 Digital Color Doppler Ultrasound System
Indications for Use:	The SonoScape S40 device is a general-purpose 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.

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

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

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

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

$m(x-h)

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

K131213 510(k) _

Indications for Use

Page 1 of 15

15

System: SonoScape S40

Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging System

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

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

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

Indications for Use

Page 2 of 15

16

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	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

Page 3 of 15

17

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
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)

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

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18

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	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
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: TD! Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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

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Indications for Use

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19

Transducer: 8P1 Phase Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General
(TRACK 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	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
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 Doppier; B/Color

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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

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Indications for Use

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20

Transducer: 6V1 Micro-curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 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)

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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

510(k) _

Indications for Use

Page 7 of 15

21

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)
	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 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

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22

Transducer: C344 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation
General
(TRACK 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	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 Doppter/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

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Indications for Use

Page 9 of 15

23

Transducer: C353 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 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; 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

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Indications for Use

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24

Transducer: C322 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application			Mode of Operation						Other*
General
(TRACK 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

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Transducer: VC6-2 Curved Array

Diagnostic Ultrasound Transducer

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

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

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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Indications for Use

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26

Transducer: L741 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 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	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	P	Note 1	Notes 2,4
	Other (specify)

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

Doppler/PWD; B/Power Doppler/PWD

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

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

Note 6: Small Organ: breast, thyroid, testes

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510(k) _

Indications for Use

Page 13 of 15

27

Transducer: L742 Linear Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 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
	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)

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

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

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

Note 6: Small Organ: breast, thyroid, testes

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Indications for Use

Page 14 of 15

28

Transducer: L752 Linear Array

Diagnostic Ultrasound Transducer

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)	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)

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

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

Doppler/PWD; B/Power Doppler/PWD

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

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

• Note 6: Small Organ: breast, thyroid, testes
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510(k) ___

Indications for Use

Page 15 of 15