PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Device Facts
| Record ID | K130119 |
|---|---|
| Device Name | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
| Applicant | Sonoscape Company Limited |
| Product Code | IYN · Radiology |
| Decision Date | Apr 12, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The SonoScape S2 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 Story
Portable digital color Doppler ultrasound system; acquires ultrasound data via various transducers (phased, curved, micro-curved, linear arrays); processes signals using all-digital architecture with progressive dynamic receive focusing; displays images in B-Mode (including Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, and 4D; operated by qualified physicians in clinical settings; exam-dependent default settings minimize user adjustment; soft-menu controls allow advanced customization; output provides diagnostic imaging for clinical evaluation; aids in diagnostic confidence and clinical decision-making.
Clinical Evidence
Bench testing only. No clinical data presented. Performance verified through acoustic output measurements, electrical/mechanical safety testing, and biocompatibility assessments per FDA-recognized standards.
Technological Characteristics
All-digital architecture; progressive dynamic receive focusing. Transducers: Phased, curved, micro-curved, linear arrays (2.0-12.0 MHz). Modes: B, M, PWD, CWD, Color Doppler, Power Doppler, TDI, THI, 4D. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-5, ISO 10993-10.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, trans-rectal, trans-vaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), OB/Gyn, and urology applications.
Regulatory Classification
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.
Predicate Devices
- SonoScape S6 (K112602)
Related Devices
- K132768 — S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Oct 4, 2013
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Aug 28, 2015
- K160283 — S45 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Apr 4, 2016
- K142714 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Company Limited · Jan 29, 2015
Submission Summary (Full Text)
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APR 1 2 2013
510(k) Submission
# 510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92]
## 1. Date Prepared [21 CFR807.92 (a) (1)]
December 30, 2012
### 2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | SonoScape Company Limited |
|------------------|---------------------------------------------------------------------|
| Address: | Yizhe Building, Yuquan Road, Nanshan, Shenzhen<br>518051, P.R.China |
| Contact Name: | Zhou Wenping |
| Telephone No.: | +86 755 26722890 |
| Fax No. : | +86 755 26722850 |
| Email Address: | Zhou@sonoscape.net / Faith@sonoscape.net |
## 3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | S2 Portable Digital Color Doppler Ultrasound System | | |
|---------------------------------------------------------|-----------------------------------------------------|-------------------|--|
| Common Name: | Diagnostic Ultrasound System and Transducers | | |
| Classification: | | | |
| 21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System | | Product code: IYN | |
| 21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System | | Product code: IYO | |
| 21 CFR892.1570 Diagnostic Ultrasonic Transducer | | Product code: ITX | |
| Classification Panel: | Radiology | | |
| Device Class: | II | | |
## 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicates within this submission are as follows:
510(k) Summary of Safety and Effectiveness
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K130119 Page 2 of 5
510(k) Submission
SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date – November 07, 2011).
## 5. Description of the Device [21 CFR 807.92(a)(4)]
The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
## 6. Intended Use [21 CFR 807.92(a)(5)]
The SonoScape S2 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. Technological Characteristics [21 CFR 807.92(a)(6)]
| No. | Probe | Type | Frequency<br>Range | Intended Use |
|-----|-------|-----------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1 | 2P1 | Phased Array | 2.0-4.0 MHz | Abdominal |
| | | | | Neonatal Cephalic |
| No. | Probe | Type | Frequency<br>Range | Intended Use |
| | | | | Adult Cephalic<br>Cardiac Adult<br>Cardiac Pediatric |
| 2 | 5P1 | Phased Array | 4.0-7.0 MHz | Pediatric<br>Neonatal Cephalic<br>Cardiac Pediatric |
| 3 | 6V1 | Micro-curved<br>Array | 4.0-8.0 MHz | Trans-rectal<br>Trans-vaginal |
| 4 | 6V3 | Micro-curved<br>Array | 5.0-9.0 MHz | Trans-rectal<br>Trans-vaginal |
| 5 | EC9-5 | Micro-curved<br>Array | 5.0-9.0 MHz | Trans-rectal<br>Trans-vaginal |
| 6 | C611 | Micro-curved<br>Array | 4.0-8.0 MHz | Abdominal<br>Pediatric<br>Neonatal Cephalic<br>Cardiac Pediatric |
| 7 | C344 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 8 | C362 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 9 | VC6-2 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 10 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid,testes)<br>Musculo-skeletal (Conventional)<br>Peripheral vessel |
| 11 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (reast, thyroid,testes)<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Peripheral vessel |
| 12 | L743 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid,testes)<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Peripheral vessel |
| 13 | C354 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
#### Table 1 Transducer Information
510(k) Summary of Safety and Effectiveness
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K130119 Page 3 of 5
Portable Digital Color Doppler Ultrasound System
510(k) Submission
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KB0119 Page 4 of 5
510(k) Submission
510(k) Submission
## 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
#### Safety Considerations:
The S2 Portable Digital Color Doppler Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers "issued September 9, 2008. 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. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-5and ISO 10993-10. Testing:
Laboratory testing was conducted to verify that the S2 Portable Digital Color Doppler Ultrasound System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. 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. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".
| Standards<br>No. | Standards Title | Version | Date |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|
| IEC 60601-1 | Medical Electrical Equipment - Part1.<br>General Requirements for Safety | 1988+A1:<br>1991+A2:<br>1995 | 10/31/2005 |
| IEC<br>60601-1-2 | Medical Electrical Equipment, Part 1-2:<br>General Requirements for Safety –<br>Collateral Standard: Electromagnetic<br>Compatibility – Requirements and Tests | 2007 | 03/01/2007 |
| IEC | Medical Electrical Equipment, Part 2-37: | 2007 | 08/01/2007 |
#### Tab 2 Applicable Safety Standards
510(k) Summary of Safety and Effectiveness
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K130119 Page 5f5
510(k) Submission
Portable Digital Color Doppler Ultrasound System
| 60601-2-37 | Particular Requirements for the Safety of<br>Ultrasonic Medical Diagnostic and<br>Monitoring Equipment | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|------|------------------------|
| NEMA UD 2 | Acoustic Output Measurement Standard for<br>Diagnostic Ultrasound Equipment Version 3 | 2004 | 01/01/2004<br>(R 2009) |
| NEMA UD3 | Standard for Real-Time Display of Thermal<br>and Mechanical Acoustic Output Indices on<br>Diagnostic Ultrasound Equipment | 2004 | 01/01/2004<br>(R 2009) |
| ISO 10993-5 | Biological evaluation of medical devices -<br>Part 5: Tests for In Vitro cytotoxicity | 1999 | 09/12/2007 |
| ISO<br>10993-10 | Biological evaluation of medical devices -<br>Part 10: Tests for irritation and delayed-type<br>hypersensitivity | 2002 | 09/01/2002 |
Results of performance and compliance testing conducted on the S2 Portable Digital Color Doppler Ultrasound System, indicates conformance to all applicable standards recognized by FDA for this device.
Based on non-clinical test results, \$2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices in safety and effectiveness.
## 9. Conclusion [21 CFR 807.92(b) (3)]
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 S2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
SonoScape Company Limited % Miss Toki Wu Official Correspondent Yizhe Building, Yuquan Road Nanshan, Shenzhen 518051 P.R. CHINA
Re: K130119
Trade/Device Name: S2 Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 28, 2012 Received: February 20, 2013
Dear Miss 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.
This determination of substantial equivalence applies to the following transducers intended for use with the S2 Portable 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 Array L742 Linear Array
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number: K130119
Device Name: S2 Portable Digital Color Doppler Ultrasound System
Indications for Use:
The SonoScape S2 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 801 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 (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> 510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119
{8}------------------------------------------------
System: SonoScape S2
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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | 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 | P | P | P | | P | P | Note 1 | Notes 2 |
| | Small Organ (specify) | P | P | P | | P | P | Note 1 | Notes 2,5 |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 |
| Fetal<br>Imaging&<br>Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 |
| | 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<br>(Conventional) | P | P | P | | P | P | Note 1 | Notes 2 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | Note 1 | Notes 2 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3 |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 |
| Cardiac | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | Notes 2 |
| | 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) _______________________________________________________________________________________________________________________________________________________________________ K130119
Indications for Use
Page 2 of 15
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Transducer: 2P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------|------------------------------------|-------------------|---|-----|-----|---------|------------------------|----------|-----------|--|
| General | Specific | | | | | Color | Power | Other* | Other* | |
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude)<br>Doppler | Combined | Specify | |
| ONLY) | | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal | Fetal | | | | | | | | | |
| Imaging&<br>Other | Abdominal | P | P | P | | P | P | Note 1 | Notes 2 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>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: 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) _______________________________________________________________________________________________________________________________________________________________________ K130119
{10}------------------------------------------------
Transducer: 5P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | Other* | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|----------|-----------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(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 | | | | | | | | | |
| Peripheral<br>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: 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)
{11}------------------------------------------------
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 | Specific | | | | | Color | Power | Other* | Other* | |
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude) | Combined | Specify | |
| ONLY) | | | | | | | Doppler | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal | Fetal | | | | | | | | | |
| Imaging& | Abdominal | | | | | | | | | |
| Other | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | p | | P | P | Note 1 | Notes 2 | |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Notes 2 | |
| | Trans-urethral | | | | | | t | | | |
| | 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) | | | | | | | | | |
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) ======================================================================================================================================================================= K130119
Indications for Use
Page 5 of 15
{12}------------------------------------------------
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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>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: 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) _________K130119
{13}------------------------------------------------
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 | | | | | | Other* | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|----------|---------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>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: 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) K130119
Indications for Use
Page 7 of 15
{14}------------------------------------------------
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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(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<br>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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
i 510(k)
{15}------------------------------------------------
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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal | Fetal | P | P | P | | P | P | Note 1 | Notes 2 | |
| Imaging &<br>Other | Abdominal | P | P | P | | P | P | 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<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(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<br>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: 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) == K130119
Indications for Use
Page 9 of 15
{16}------------------------------------------------
Transducer: C344 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | Other* | |
|------------------------------|------------------------------------|-------------------|-------------------|-----|-----|------------------|---------------------------------|----------|---------|--------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined | Specify | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | P | P | P | | P | P | Note 1 | Notes 2 | | |
| | Abdominal | P | P | P | | P | P | 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<br>(Conventional) | | | | | | | | | | |
| | Musculo-skeletal<br>(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<br>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) K130119
Indications for Use
Page 10 of 15
{17}------------------------------------------------
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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| Fetal | Fetal | N | N | N | | N | N | Note 1 | Notes 2 | | | |
| Imaging& | Abdominal | N | N | N | | N | N | 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) | N | N | N | | Z | N | Note 1 | Notes 2 | | | |
| Cardiac | Cardiac Adult…
