CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM

K120321 · Philips Health Care · IYN · Feb 17, 2012 · Radiology

Device Facts

• Record ID: K120321
• Device Name: CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Philips Health Care
• Product Code: IYN · Radiology
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

ClearVue 350/550 is intended for diagnostic ultrasound imaging and fluid flow analysis.

Device Story

ClearVue 350/550 is a general imaging/shared-service ultrasound system. It accepts acoustic signals via transducers (S4-1, C5-2, C9-4v, L12-4) and transforms them into diagnostic images and fluid flow data using standard ultrasound signal processing (B-mode, M-mode, Doppler, Tissue Harmonics, SonoCT, X-Res, iSCAN). Used in hospitals, clinics, and medical offices by clinicians. Output is displayed on an integrated monitor for real-time visualization, assisting in diagnosis, biopsy guidance, and follicle monitoring. Benefits include non-invasive diagnostic imaging and hemodynamic assessment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 standards.

Technological Characteristics

Track 3 diagnostic ultrasound system. Features B-mode, M-mode, Pulse/Continuous Wave Doppler, Color Doppler, Tissue Harmonics, SonoCT, X-Res, and iSCAN. Transducers: S4-1, C5-2, C9-4v, L12-4. Materials evaluated for biocompatibility per ISO 10993. Complies with IEC 60601 series safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetric, abdominal, pediatric, small organ (thyroid, scrotum, prostate, breast), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional/superficial), gynecological, cardiac (adult/pediatric), fetal, peripheral vessel, and carotid applications. Includes biopsy guidance and infertility monitoring of follicle development.

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

• HD11 Diagnostic Ultrasound System (K043535)

Submission Summary (Full Text)

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K120321

# FEB 1 7 2012

# Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92.

## 1) Submitter's name, address, telephone number, contact person

Rob Butler Senior Manager, Regulatory Affairs Philips Ultrasound, Inc. 3000 Minuteman Road Andover. MA 01810-6302 Tel: [phone] Fax: [phone]

Date prepared: January 26, 2012.

## Manufacturer's Name, Manufacturing Name, and Initial distributor:

Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

#### Establishment Registration Number:

Philips Ultrasound, Inc. 1217116

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name: Diagnostic ultrasound system and transducers

ClearVue 350/550 Diagnostic Ultrasound System Proprietary Name:

Classification Name: Class II

| 21 CFR<br>Section | Classification Name | Product Code |
|-------------------|------------------------------------------------|--------------|
| 892.1550 | System, Imaging, Pulsed Doppler,<br>Ultrasonic | 90 IYN |
| 892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | 90 IYO |
| 892.1570 | Transducer, Ultrasonic, diagnostic | 90 ITX |

## 3) Substantially Equivalent Device

HD11 Diagnostic Ultrasound System K043535

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# 3) Device Description

ClearVue 350/550 is a new general imaging or shared-service ultrasound system from Philips Ultrasound. The 550 model has more complete features than the 350, and an articulating arm for mounting of the display (the 350 has a tilt-swivel mount for the display). ClearVue provides excellent ultrasound capabilities in a lightweight, affordable system. Its intended use and indications for use are standard for general imaging and shared-service (general imaging + cardiac) systems, and are within the cleared intended use and indications for use for the Philips HD11 diagnostic ultrasound system (cleared in K043535), to which ClearVue is substantially equivalent.

# 4) Intended Use

ClearVue 350/550 is intended for diagnostic ultrasound imaging and fluid flow analysis.

# 5) Technological comparison to predicate devices

Philips ClearVue 350/550 and HD11 Diagnostic Ultrasound Systems are Track 3 systems that employ the same fundamental scientific technology.

# 6) Determination of Substantial Equivalence

## Non-clinical performance data

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

- IEC 60601-1: Medical electrical equipment. General requirements for basic safety and . essential performance
- IEC 60601-1-1: Medical Electrical Equipment Part 1: General Requirements for Safety; . Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for . Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of . ultrasonic medical diagnostic and monitoring equipment
- ISO 10993: Biological evaluation of medical devices. .

## Summary of Clinical Tests

ClearVue 350/550 introduces no new indications for use, modes, features, or technologies relative to the predicate device (HD11- K0433535) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

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## 7) Conclusions

Philips ClearVue 350/550 is substantially equivalent in safety and effectiveness to the predicate identified above:

- The predicate device and ClearVue 350/550 are indicated for the diagnostic ultrasonic . imaging and fluid flow analysis.
- The predicate device and ClearVue 350/550 have the same gray-scale and Doppler . capabilities.
- The predicate device and ClearVue 350/550 use essentially the same technologies for . imaging. Doppler functions and signal processing.
- The predicate device and ClearVue 350/550 have acoustic output levels below the Track . 3 FDA limits.
- The predicate device and ClearVue 350/550 are manufactured under equivalent quality . systems.
- The predicate device and ClearVue 350/550 are manufactured of materials with . equivalent bio safety. The materials have been evaluated and found to be safe for this application.
- The predicate device and ClearVue 350/550 are designed and manufactured to the same . electrical and physical safety standards.

## 514 Performance Standards

There are no Sec. 514 performance standards for this device.

## Prescription Status

This is a prescription device. The prescription device statement appears in the labeling.

## Sterilization Site(s)

Not applicable. No components supplied sterile.

## Reason for Submission

This submission is for the first (1.0) release of the ClearVue 350/550 diagnostic ultrasound system from Philips Ultrasound. This is a new diagnostic ultrasound system, substantially equivalent to the predicate device.

## Track

This is a Track 3 system.

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

FEB 1 7 2012

Re: K120321

Trade/Device Name: ClearVue 350/550 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO and ITX Dated: February 1, 2012 Received: February 2, 2012

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the ClearVue 350/550 Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

| S4-1 |
|-------|
| C5-2 |
| C9-4v |
| L12-4 |

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

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

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

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely Yours,

Mary S. Patil for

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use Form

510(k) Number (if known):

Device Name: ClearVue 350/550 Diagnostic Ultrasound System

Indications for Use: The ClearVue 350/550 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Harmonics, iSCAN, X-Res, angio, 3D (freehand), and SonoCT. The system may also be used in biopsy guidance and to assist in infertility monitoring of follicle development (OB). The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Forms (included in the submittal):

> Fetal / Obstetric Abdominal Pediatric Small Organ (thyroid, scrotum, prostate, breast) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculoskeletal (conventional) Musculoskeletal (superficial) Other - Gynecological Cardiac Adult Cardiac Pediatric Cardiac Other - Fetal Peripheral Vessel Peripheral Vessel Other - Carotid

The clinical environments where the ClearVue 350/550 Diagnostic Ultrasound System can be used include hospital, clinical and medical office settings for diagnosis of patients. The use models for ClearVue 350/550 are within the scope of and substantially equivalent to current indications for use for Diagnostic Ultrasound System.

| Prescription Use<br>(Part 21 CFR 801 Subpart D)<br>X | AND/OR | Over-The-Counter Use<br>(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 Diagnostic Devices (OIVD)

Mury Shatel

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety nians 510(k)_

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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510(k) Number:

ClearVue 350/550 Diagnostic Ultrasound System Device name:

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------|---|-----|-----|------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | N | N | N | N | N | N | N(1-7) |
| | Abdominal | N | N | N | N | N | N | N(1-7) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | N | N | N | N(1-7) |
| | Small Organ (thyroid,<br>scrotum, prostate, breast) | N | N | N | N | N | N | N(1-7) |
| | Neonatal Cephalic | N | N | N | N | N | N | N(1-7) |
| | Adult Cephalic | N | N | N | N | N | N | N(1-7) |
| | Trans-rectal | N | N | N | N | N | N | N(2-7) |
| | Trans-vaginal | N | N | N | N | N | N | N(2-8) |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel<br>(conventional) | N | N | N | N | N | N | N(1-7) |
| | Musculo-skel (superficial) | N | N | N | N | N | N | N(1-7) |
| | Other (Gynecological) | N | N | N | N | N | N | N(1-8) |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N(1-3,5,7) |
| | Cardiac Pediatric | N | N | N | N | N | N | N(1-3,5,7) |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | N | N | N | N | N | N | N(1-7) |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N(1-7) |
| | Other (Carotid) | N | N | N | N | N | N | N(1-7) |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | 5. 3D (Freedhand) Imaging | | | | | | |
| 1. Tissue Harmonics | | 6. SonoCT | | | | | | |
| 2. iSCAN | | 7. Biopsy guidance | | | | | | |
| 3. X-Res | | 8. Infertility monitoring of follicle development | | | | | | |

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (FLEASE DO NOT WRITE BEBOW TITIO EXTO EXTERNET, Office of In Vitro Diagnostics

4. Anglo magnite
Combined modes: B+PWD, B+Color, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD

Prescription Use (Per 21 CFR 801.109)

Mary S. Patil

4. Angio imaging

Previous submission: none

Division Sign Division of Radiological Devices Office of In tion and Safety 610K

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510(k) Number:

S4-1 transducer used with ClearVue 350/550 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------|---|-----|-----|------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | N | N | N | N | N | N | N(1-5,7) |
| | Abdominal | N | N | N | N | N | N | N(1-5,7) |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | N | N | N | N(1-5,7) |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N(1-5,7) |
| | Adult Cephalic | N | N | N | N | N | N | N(1-5,7) |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | N | N | N | N | N | N | N(1-5,7,8) |
| | Cardiac Adult | N | N | N | N | N | N | N(1-3,5,7) |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N(1-3,5,7) |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | N | N | N | N | N | N | N(1-3,5,7) |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: | | | | | | | | |
| 1. Tissue Harmonics | | 5. 3D (Freehand) Imaging | | | | | | |
| 2. iSCAN | | 6. SonoCT | | | | | | |
| 3. X-Res | | 7. Biopsy guidance | | | | | | |
| 4. Angio imaging | | 8. Infertility monitoring of follicle development | | | | | | |
| Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | | | | | | | | |

Previous submission: none

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

vision of Radiological Device Evaluation and Safety

Mary Patel
(Division Sign-Off)
Division of Radiological Devices
's Device Evaluation and S

Office of In Vit

દિવાસ

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510(k) Number:

Device name: C5-2 transducer used with ClearVue 350/550 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------|-------------------------------------------------------------|---|-------------------|-----|-----|---------------------------------------------------|------------------------------------|---------------------|--|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetric | N | N | N | | N | N | N(1-7) | |
| | Abdominal | N | N | N | | N | N | N(1-7) | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | | N | N | N(1-7) | |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | N | N | N | | N | N | N(1-7) | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | | |
| | Other (Gynecological) | N | N | N | | N | N | N(1-8) | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Fetal) | N | N | N | | N | N | N(1-7) | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | |
| *Other modes: | | | | | | 5. 3D (Freehand) Imaging | | | |
| 1. Tissue Harmonics | | | | | | 6. SonoCT<br>7. Biopsy guidance | | | |
| 2. iSCAN | | | | | | | | | |
| 3. X-Res | | | | | | 8. Infertility monitoring of follicle development | | | |
| 4. Angio imaging | | | | | | | | | |
| | Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD | | | | | | | | |
| Previous submission: none | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (I CENSE DO TO T WATER and Radiological Health, Office of In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

દાભ

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510(k) Number:

C9-4v transducer used with ClearVue 350/550 Diagnostic Ultrasound System Device name: 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 I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | N | N | N | | N | N | N(2-7) |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (thyroid, scrotum,<br>prostate, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N(2-7) |
| | Trans-vaginal | N | N | N | | N | N | N(2-8) |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Other (Gynecological) | N | N | N | | N | N | N(2-8) |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
| *Other modes: | 1. Tissue Harmonics | | 5. 3D (Freehand) Imaging | | | | | |
| 2. iSCAN | | | 6. SonoCT | | | | | |
| 3. X-Res | | | 7. Biopsy guidance | | | | | |
| 4. Angio imaging | | | 8. Infertility monitoring of follicle development | | | | | |
| | Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD | | | | | | | |
| Previous submission: none | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (I LEASE DO NOT W RTD BEBO... 11 Radiological Health, Office of In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

Mary S. Patil

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diag ostic Device Evaluation and Safety 510K

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510(k) Number:

L 12-4 transducer used with Clear Vue 350/550 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|----------------------------------------------------------------------------|-------------------|---------------------------------------------------|-----|-----|--------------------------|------------------------------------|---------------------|
| General<br>(Track I<br>Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>See below | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | | N | N | N(1-7) |
| | Small Organ (thyroid, scrotum,<br>prostate, breast) | N | N | N | | N | N | N(1-7) |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Musculo-skel (conventional) | N | N | N | | N | N | N(1-7) |
| | Musculo-skel (superficial) | N | N | N | | N | N | N(1-7) |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Fetal) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N(1-7) |
| | Other (Carotid) | N | N | N | | N | N | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
| *Other modes: | | | | | | 5. 3D (Freehand) Imaging | | |
| 1. Tissue Harmonics | | | 6. SonoCT | | | | | |
| 2. iSCAN | | | 7. Biopsy guidance | | | | | |
| 3. X-Res | | | 8. Infertility monitoring of follicle development | | | | | |
| 4. Angio imaging | | | | | | | | |
| | Combined modes: B+PWD, B+Color, B+M, B+Color+PWD | | | | | | | |
| Previous submission: none | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

Prescription Use (Per 21 CFR 801.109)

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Division of Radiological Devices Division of Hadlological Device Evaluation and Selety BIOK