Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary does not mention AI, ML, or any related terms, and the device description focuses on traditional ultrasound imaging technology and processing.

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". It is not intended for treatment or therapy.

Diagnostic

Yes

The device description explicitly states, "This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system." It also mentions its use for "clinical diagnostic imaging applications" and enhancing "diagnostic utility and confidence."

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.

IVD (In Vitro Diagnostic)

Based on the provided information, the SonoScape S11 device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a general-purpose ultrasonic imaging instrument for evaluating various anatomical sites in patients. This involves imaging within the body.
Device Description: The description details an ultrasound system that acquires ultrasound data and displays images. This is consistent with in-vivo imaging.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The SonoScape S11 does not perform such tests on samples.

The SonoScape S11 is a medical imaging device used for diagnostic purposes in vivo (within a living organism), not in vitro (in a test tube or other artificial environment).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoScape S11 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 (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The SonoScape S11 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, 4D.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed doppler, Ultrasonic pulsed echo

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, Urology.

Indicated Patient Age Range

Neonatal and adult (for cephalic and cardiac)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Laboratory testing was conducted to verify that the S11 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". No clinical testing was required.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112602

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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) Summary

JUN 1 4 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: __________________________________________________________________________________________________________________________________________________

1. Date of submission: March 13, 2013

2. Submitter

SonoScape Company Limited

Address: Yizhe Building, Yuquan Road, Nanshan, Shenzhen 518051, P.R. China

Tel: (86) 755-26722890

Fax: (86) 755-26722850

Contact Person: Toki Wu

E-mail:Faith@sonoscape.net/wusq@sonoscape.net

3. Proposed Device Identification

Trade/Proprietary Name: S11 Digital Color Doppler Ultrasound System Common Name: Diagnostic Ultrasound System and Transducers Classification:

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

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

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Classification Panel: Radiology

Device Class: II

4. Legally Marketed Predicate Device

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

510(k) Summary

1

5. Device Description

The SonoScape S11 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, 4D.

6. Intended Use Statement

The SonoScape S11 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 S11 system with added transducer met all design specification and was substantially equivalent to the Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output

510(k) Summary

2

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

IEC 60601-1: 1988+A1:1991+A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety

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

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

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

8. Clinical Test:

No clinical testing was required.

9. Comparison Table

The differences between the S11 and the predicate device S6 in almost every part are listed in the tables below.

| ID | Comparison
Items | Proposed Device
Sonoscape S11 | 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 | SE |
| 3 | Product
Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | SE |
| ID | Comparison
Items | Proposed Device
Sonoscape S11 | Predicate Device
Sonoscape S6 | Remark |
| 4 | Regulation
Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | SE |
| 5 | Panel | Radiology | Radiology | SE |
| 6 | Class | II | II | SE |
| 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. | SE |
| 7 | Probe Type
&
Connectors | L741 Linear Array, 5.0-10.0
MHz
L742 Linear Array, 5.0-12.0
MHz
L743 Linear Array, 5.0-10.0
MHz
C344 Curved Array, 2.0-5.0
MHz
C362 Curved Array, 2.0-6.0
MHz
C354 Curved Array, 2.0-5.0
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
EC9-5 Micro-curved Array,
5.0-9.0 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
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
EC9-5 Micro-curved Array,
5.0-9.0 MHz | SE
Analysis
1
SE
SE
SE |
| | | 2P1 Phased Array, 2.0-4.0 MHz | 2P1 Phased Array, 2.0-4.0 MHz | SE |
| ID | Comparison Items | Proposed Device
Sonoscape S11 | Predicate Device
Sonoscape S6 | Remark |
| | | 5P1 Phased Array, 4.0-7.0 MHz | 5P1 Phased Array, 4.0-7.0 MHz | |
| | | Multi-port connector connects 3 transducers | Multi-port connector connects 2 transducers | SE
Analysis
2 |
| 8 | Acoustic Track | TRACK 3 | TRACK 3 | SE |

Table 1 General Comparison

510(k) Summary

3

SonoScape Company Limited

510(k) Submission

510(k) Summary

.

4

SonoScape Company Limited

510(k) Submission

Table 2 Functions Comparison

| ID | Comparison
Items | Proposed Device
SonoScape S11 | Predicate Device
SonoScape S6 | Remark |
|----|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 9 | Design | Based on an embedded Linux
operating system.
Based on a 64 channel full
digital beam former.
Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing.
Supporting Linear, Curve linear
and Phase array probes from 2
to 15 MHz.
Cine play back capability
Image file archive
Software upgrades with USB
flash drive.
Digital Scan Converter
800×600
TGC 8 slider
Depth Range: 3 to 32 cm
Image sector size: 32 lines to
full B (256 lines)
Image Sector position: Steering
within full maximum | Based on an embedded Linux
operating system.
Based on a 64 channel full
digital beam former.
Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing.
Supporting Linear, Curve linear
and Phase array probes from 2
to 15 MHz.
Cine play back capability
Image file archive
Software upgrades with USB
flash drive.
Digital Scan Converter
800×600
TGC 8 slider
Depth Range: 3 to 32 cm
Image sector size: 32 lines to
full B (256 lines)
Image Sector position: Steering
within full maximum | SE |
| 10 | Operation
Controls | B orientation flip :L/R key with
marking on the screen
B Dynamic range control:
preset 14 curves over 140 dB
Gray Scale Control: 7 Settings
Focal Number: 12 focal zone
setting
B persistence: 0-95%
Image Processing: Smoothing | B orientation flip :L/R key with
marking on the screen
B Dynamic range control:
preset 14 curves over 140 dB
Gray Scale Control: 7 Settings
Focal Number: 12 focal zone
setting
B persistence: 0-95%
Image Processing: Smoothing | SE |
| | Comparison | Proposed Device | Predicate Device | |
| ID | Items | SonoScape S11 | SonoScape S6 | Remark |
| | | edge enhancement | edge enhancement | |
| | | PW sweeping speed 2,4,6,8 | PW sweeping speed 2,4,6,8 | SE |
| | | sec over display | sec over display | |
| | | PW Wall filter setting: 16 | PW Wall filter setting: 16 | SE |
| | | settings,25 to 750 HZ | settings,25 to 750 HZ | |
| | | PW sample volume:0.5 to | PW sample volume:0.5 to | SE |
| | | 20mm | 20mm | |
| | | PW/B update: with UPDATE | PW/B update: with UPDATE | SE |
| | | key | key | |
| | | PW cursor steering: Steer soft | PW cursor steering: Steer soft | SE |
| | | key | key | |
| | | PW angle correction:0 to 80 | PW angle correction:0 to 80 | SE |
| | | degree user control | degree user control | |
| | | PW spectrum dynamic | PW spectrum dynamic | SE |
| | | range: 10 preset curve over | range:10 preset curve over | |
| | | 15-48 dB | 15-48 dB | |
| | | Spectrum baseline shift and | Spectrum baseline shift and | SE |
| | | invert | invert | |
| | | Color ROI setting: trackball and | Color ROI setting: trackball and | SE |
| | | set key to control size and | set key to control size and | |
| | | position | position | |
| | | Color steering on flat probe:±20 | Color steering on flat probe:±20 | SE |
| | | ±160 | ±160 | |
| | | Color Wall Filter: Color wall | Color Wall Filter: Color wall | SE |
| | | filter with 16 selection, 25-750 | filter with 16 selection, 25-750 | |
| | | of PRF | of PRF | |
| | | Color priority-B priority soft | Color priority-B priority soft | SE |
| | | menu | menu | |
| | | Color Packet size: preset per | Color Packet size: preset per | SE |
| | | Exam, horizontal, vertical, off | Exam, horizontal, vertical, off | |
| | | Zoom adjustable | Zoom adjustable | SE |
| | | Freeze control: Toggling freeze | Freeze control: Toggling freeze | SE |
| | | key | key | |
| | | Cine control: step, play | Cine control: step, play | SE |
| | | backward, play continuously | backward, play continuously | |
| 11 | Operation | B, M, PW, CW, CFM, DPI, TDI, | B, M, PW, CW, CFM, DPI, TDI, | SE |
| | Mode | Tissue Harmonic Image | Tissue Harmonic Image | Analysis |
| | | 4D Mode | 3D/4D Mode | 3 |
| | | Color M Mode | Color M Mode | |
| 12 | Display | Dual B, Quad Display, | Dual B, Quad Display, | SE |
| | Modes | B and M, B and Doppler | B and M, B and Doppler | |
| ID | Comparison
Items | Proposed Device
SonoScape S11 | Predicate Device
SonoScape S6 | Remark |
| | | B + Color, Dual B(Flow) | B + Color, Dual B(Flow) | |
| | | Triplex mode: B,CFM, and | Triplex mode: B,CFM, and | |
| | | PW/CW; B,DPI, and | PW/CW; B,DPI, and | |
| | | PW/CW;B,THI and Color M,
steer M | PW/CW;B,THI and Color M,
steer M | |
| | | Dual B and Color in real time | Dual B and Color in real time | |
| | | Compound Imaging, | Compound Imaging, | |
| | | Panoramic Imaging, | Panoramic Imaging, | |
| | | Trapezoid Imaging. | Trapezoid Imaging. | |
| | | | | |
| 13 | Measureme
nt Items | Distance; area; circumference; | Distance; area; circumference; | SE |
| | | calipers; volume, velocity, HR, | calipers; volume, velocity, HR, | |
| | | PI, RI. Cardiac. OB/GYN, | PI, RI. Cardiac. OB/GYN, | |
| | | Urology, Vascular and small | Urology, Vascular and small | |
| | | part package | part package | |
| 14 | Cine Loop | Automatic review/ manual
review | Automatic review/ manual
review | SE |
| | | | | |
| | | Review speed can't be adjust | Review speed can be adjust | SE |

ි බ

5

SonoScape Company Limited

510(k) Submission

:

510(k) Summary

6

SonoScape Company Limited

Table 3 Specifications Comparison

| ID | Comparison
Items | Proposed Device
SonoScape S11 | Predicate Device
SonoScape S6 | Remark |
|----|------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------|
| 15 | Power
Supply | Voltage: 100-240 VAC
Frequency: 50/60 Hz
Power Consumption:
100-240V AC, 2.7-1.2A | Voltage: 110-240 VAC
Frequency: 50/60 Hz
Power Consumption: 110-240V
AC, 2.7-1.2A | SE
Analysis
4 |
| 16 | Operating
Condition | Temperature: 1040°C
Relative humidity: 3085%
Air pressure: 700hPa
~~1060hPa | Temperature: 10~~40°C
Relative humidity: 3085%
Air pressure: 700hPa
1060hPa | SE |
| 17 | Storage
Condition | Temperature: -2055°C
Relative humidity: 2090%
Air pressure: 700hPa
~~1060hPa | Temperature: -20~~55°C
Relative humidity: 20~90%
Air pressure: 700hPa
~1060hPa | SE |
| 18 | Screen Size | 15 inch Widescreen LCD
monitor | 15 inch Widescreen LCD
monitor | SE |
| 19 | Acoustic
Output | Track 3:MI,TIS,TIC,TIB
Derated ispta: 720Mw/cm²
maximum. | Track 3: MI,TIS,TIC,TIB
Derated ispta: 720Mw/cm²
maximum. | SE |

7

SonoScape Company Limited

| ID | Comparison
Items | Proposed Device
SonoScape S11 | Predicate Device
SonoScape S6 | Remark |
|----|---------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------|
| | | TIS/TIB/TIC: 6.0 Maximum,
Mechanical Index: 1.9
Maximum, or Derated Isppa:
190W/cm² max | TIS/TIB/TIC: 6.0 Maximum,
Mechanical Index: 1.9
Maximum, or Derated Isppa:
190W/cm² max | |

Table 4 Safety Comparison

| ID | Comparison
Items | Proposed Device
Sonoscape S11 | Predicate Device
Sonoscape S6 | Remark |
|----|------------------------------------|-------------------------------------|-------------------------------------|--------|
| 20 | Electrical Safety | -IEC 60601-1 | -IEC 60601-1 | SE |
| 21 | EMC | -IEC 60601-1-2 | -IEC 60601-1-2 | SE |
| 22 | Performance | -IEC 60601-2-37 | -IEC 60601-2-37 | SE |
| 23 | Biocompatibility | -ISO 10993-5,
-ISO 10993-10 | -ISO 10993-5,
-ISO 10993-10 | SE |
| 24 | Level of
Concern Of
Software | Moderate level of concern
system | Moderate level of concern
system | SE |

SE Analysis 1

Compare to the predicate device, the proposed device is with one more probe C354. But the intended use of C354 is the same to the C344 and C362, no new intended use is added, therefore, the intended use could be considered Substantially Equivalent.

SE Analysis 2

The proposed device has 3 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.

SE Analysis 3

Operation Mode, compare to the predicate device, the proposed device doesn't have 3D function. But both of them comply with AAMI UD2 and IEC 60601-2-37. Therefore, they are considered to be substantially equivalent, so the SE is not affected.

SE Analysis 4

The Voltage of the proposed device and the predicate device are 100-240 VAC and 110-240 VAC 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.

:

8

K130801
Page 9 of 9

Discussion of Substantially Equivalent

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

10. Substantially Equivalent Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S11 Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

510(k) Summary

9

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

June 14, 2013 .

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

Re: K130801

Trade/Device Name: S11 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: March 13, 2013 Received: March 22, 2013

Dear Ms. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 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 for use with the SII Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1 Phase Array 5P1 Phase Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array C344 Curved Array . C354 Curved Array VC6-2 Curved Array

L743 Linear Array L741 Linear Arrav L742 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 (800) 638 2041 or (301) 796-7100 or at its Internet address

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

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

-Sincerely-yours;-

Smh?)

for

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

Enclosure

11

Indications for Use

510(k) Number: K130801

Device Name: S11 Digital Color Doppler Ultrasound System

Indications for Use:

The SonoScape S11 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.

-Over-The-Counter Use. -AND/OR-Prescription-Use .. (21-GFR-801-Subpart-C)-(Part 21-CFR 801-Subpart D)

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

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

Sm. 7)

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

K130801 510(k)

12

System: SonoScape S11

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
	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
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,5
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3
Fetal	Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3
Imaging&	Trans-rectal	N	N	N		N	N	Note 1	Notes 2
Other	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	N	N	N		N	N	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	N	N	N		N	N	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4
	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3
Cardiac	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2
Vessel	Other (specify)

E = added under this ppendix N = new indication; P = previously cleared by FDA; 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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

510(k) K130801

Indications for Use

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

Note 5: Small Organ: breast, thyroid, testes

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

510(k) K130801

Indications for Use

14

" Transducer: 5P1 Phase Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 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
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	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
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

E = added under this appendix N = new indication; P = previously cleared by FDA; 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: 4D Note 3: TDI

Note 5: Small Organ; breast, thyroid, testes

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

510(k) K130801

Indications for Use

15

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
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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	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 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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

510(k) K130801

16

Transducer: 6V3 Micro-curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(TRACK 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
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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)

E = added under this appendix P = previously cleared by FDA; 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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

Indications for Use

17

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	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

510(k) K130801

18

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
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
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	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
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

E = added under this appendix N = new indication; P = previously cleared by FDA; 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: 4D Note 3: TDI

Note 5: Small Organ: breast, thyroid, testes

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

K130801 510(k) -

19

Transducer: C362 Curved Array

Diagnostic Ultrasound Transducer

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

Clinical Application		Mode of Operation
General
(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
Imaging &	Abdominal	P	P	P		P	P	Note1	Notes 2
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	Note1	Notes 2
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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

K130801 510(k)

20

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	Fetal	P	P	P		P	P	Note 1	Notes 2
Imaging&	Abdominal	P	P	P		P	P	Note 1	Notes 2
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
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

E = added under this appendix N = new indication; P = previously cleared by FDA; 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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

510(k)

Indications for Use

21

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
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	N	N	N		N	N	Note 1	Notes 2
	Abdominal	N	N	N		N	N	Note 1	Notes 2
	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
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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

K130801 510(k)

Indications for Use

22

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
Imaging &	Abdominal	P	P	P		P	P	Note 1	Notes 2.4
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(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
Vessel	Other (specify)

P = previously cleared by FDA; 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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

K130801 510(k)

Indications for Use

23

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
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&	Abdominal
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
Vessel	Other (specify)

E = added under this appendix P = previously cleared by FDA; 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: 4D Note 3: TDI

Note 5: Small Organ: breast, thyroid, testes

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

510(k) _______________________________________________________________________________________________________________________________________________________________________ K130801

Indications for Use

24

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	Fetal
Imaging&	Abdominal
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2.5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal	P	P	P		P	P	Note 1	Notes 2
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)-
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

K130801 510(k)

Indications for Use

25

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 2,5
	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
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	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	P	P		P	P	Note 1	Notes 2

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: 4D

Note 5: Small Organ: breast, thyroid, testes

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

510(k) K130801

Indications for Use