SONARA; SONARA/TEK

K060421 · Viasys Healthcare, Inc. · IYN · Nov 3, 2006 · Radiology

Device Facts

• Record ID: K060421
• Device Name: SONARA; SONARA/TEK
• Applicant: Viasys Healthcare, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [Table of clinical applications including Ophthalmic, Intraoperative, Pediatric, Neonatal Cephalic, Adult Cephalic, and Peripheral Vascular using PWD and CWD modes]. The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).

Device Story

Sonara/Sonara/tek TCD systems measure blood flow velocities and hemodynamic parameters in intracranial, extracranial, and peripheral vessels. System utilizes 2MHz, 4MHz, and 8MHz ultrasound probes in unilateral or bilateral configurations; includes 2MHz monitoring probe for headset use. Inputs processed via integrated PC/touchscreen display; provides M-mode imaging and spectral Doppler displays. Operated by clinicians in clinical or surgical settings; supports online/offline modes. Output allows real-time monitoring of blood flow and emboli detection (HITS) to assist clinical decision-making during vascular procedures or monitoring. Sonara/tek variant connects to external PC via USB.

Clinical Evidence

Bench testing only. Device subjected to safety and performance validation, including functional specification testing and compliance with IEC/EN 60601-1, 60601-1-2, and 60601-2-37 standards. Acoustic output measured per FDA 1997 ultrasound guidance.

Technological Characteristics

Pulsed Doppler ultrasound system; 2MHz, 4MHz, 8MHz transducers. Integrated 15" touch screen LCD, PC board, hard disk. Connectivity: USB (Sonara/tek). Standards: IEC/EN 60601-1, 60601-1-2, 60601-2-37. Modes: PWD, CWD, M-mode. Power levels displayed during scanning.

Indications for Use

Indicated for noninvasive measurement of blood flow velocities in intracranial, extracranial, and peripheral arteries and veins. Used for transcranial Doppler monitoring, carotid monitoring, and emboli detection (HITS) in adult, pediatric, and neonatal populations. Applicable for intraoperative use during surgical procedures. No invasive transducer application.

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

• Doppler-Box (K051085)
• TCD 100M (K002533)
• TC8080 Pioneer /Companion III (K053648)

Submission Summary (Full Text)

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## NOV - 3 2006

### 510(K) SUMMARY

# SONARA TCD SYSTEM (INCLUDING SONARA AND SONARA/TEK)

## 510(k) Number: K060421

| Applicant's Name: | VIASYS Healthcare, Inc.<br>227 Washington St., Suite 200<br>Conshohocken, PA 19428 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Contact: | Mr. Glen Hermanson<br>Global Manager, Quality Engineering<br>VIASYS NeuroCare, Inc.<br>5225 Verona Road<br>Madison, WI 53711<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | September 29, 2006 |
| Trade Name: | Sonara and Sonara/tek Transcranial Doppler (TCD) System |
| Classification Name: | CFR Classification section 892.1550 (Product code IYN); CFR<br>Classification section 892.1570 (Product code ITX) |
| Classification: | Class II medical Device |
| Predicate Device: | The Sonara and Sonar/tek TCD devices are comparable to the following<br>predicate devices: |
| | - Doppler-Box (K051085) manufactured by Compumedics Gmbh<br>(DWL). Doppler-Box is a Transcranial Doppler Ultrasound device,<br>providing similar data to the Sonara/tek device. |
| | - TCD 100M (K002533) manufactured by Spencer Technologies. TCD<br>100M is a Transcranial Doppler Ultrasound device, providing similar<br>data to the Sonara device. |
| | - TC8080 Pioneer /Companion III (K053648) manufactured by VIASYS<br>HealthCare, Inc., Neurocare Group.<br>The TC8080 Pioneer /<br>Companion III are TCD devices with equivalent indications for use. |
| Device Description: | The Sonara device is a Transcranial and peripheral vascular Doppler<br>system, which is designed to measure blood flow velocities and other<br>hemodynamic parameters in a non-invasive manner, in intracranial,<br>extracranial and peripheral blood vessels.<br>The Sonara system includes an integrated 15" touch screen color LCD<br>display, integrated PC board and hard disk for data management and |
| Performance Standards: | None.<br>The design of the Sonara and Sonara/tek Transcranial Doppler (TCD)<br>devices conforms to the following voluntary standards:<br>IEC/EN-60601-1: Medical Electrical Equipment; Part 1: General<br>Requirements for Safety. Second edition (1990), including amendments<br>#1(1993), #2(1995), #13(1996).<br>IEC/EN 60601-1-2: Medical Electrical Equipment; Part 1-2: Collateral<br>Standard: Electromagnetic Compatibility- Requirements and Tests<br>(2001)<br>IEC/EN 60601-2-37: Medical Electrical Equipment; Part 2: Particular<br>Requirements for the Safety of Ultrasonic Medical Diagnostic and<br>Monitoring Equipment (2001) |
| Acoustic Output: | Acoustic output reporting for the Sonara devices was carried in<br>compliance with "Information for manufacturers seeking marketing<br>clearance of diagnostic ultrasound systems and transducers", September<br>30, 1997 (FDA Ultrasound Guidance (1997), Table 6-3, Page 6-9. |
| Test Data: | The Sonara and Sonara/tek Transcranial and vascular Doppler devices<br>have been subjected to extensive safety, performance testing, and<br>validation before release. Final testing of the Sonara device included<br>various performance tests designed to ensure that the device met all its<br>functional specifications. Tests have been performed to ensure the<br>device complies with industry and safety standards. |
| Substantial Equivalence: | The Sonara and Sonara/tek TCD are similar to currently distributed<br>pulsed Doppler Ultrasound systems with 2MHz, 4MHz and 8MHz<br>transducers intended for transcranial and peripheral Doppler<br>applications. Maximum acoustic output levels are below pre-amendment<br>levels for acoustic intensity for this application, and for Mechanical<br>Index for all applications. Power levels are displayed at all times during<br>scanning. A standard spectrum display is shown in both viewing |

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display. The Sonara/tek is the same device, utilizing a personal computer for its opcration (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.

Intended Use / Indication for Use: The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).

### Performance Standards: None

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| | formats. The device includes an M-mode image. All of the above features are similar to these features in the predicate devices. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions: | The conclusions drawn from the above Performance Testing and comparison to Predicate devices is that the Sonara and Sonara/tek Transcranial and peripheral vascular Doppler device and transducers are substantially equivalent in safety and efficacy to the predicate devices listed above. |

:

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

VIASYS Healthcare, Inc., NeuroCare Group % Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane MADISON WI 53711

Re: K060421

Trade Name: Sonara and Sonara/tek Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN and ITX Dated: October 6, 2006 Received: October 10, 2006

Dear Mr. Syring:

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 Sonara and Sonara/tek Systems, as described in your premarket notification:

Transducer Model Number

2 MHz PW Hand-Held Transducer 2 MHz PW Monitoring Transducer 4 MHz Transducer 8 MHz Transducer

Image /page/3/Picture/14 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are in the center. The word "Centennial" is below the letters. There are three stars below the word "Centennial". The text "Dedicated to Protecting and Promoting Your Health" surrounds the circle.

*Protecting and Promoting Public Health*

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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 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Dr. Ewa Czerska at [phone] .

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## Sonara System

#### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | X | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | X | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | X | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | X | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | X | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

an her marcanent of the Sonara device can be used during surgery to support Transcranial Doppler
Additional Comments:

Monitoring, Carotid Monitoring, Emboli Detection (HITS).

No associated transducer probes are applied invasively.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510k) Number _

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## Sonara/tek System

Appendix F

#### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|------------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | X | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | X | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | X | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | X | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | X | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | |

Additional Comments: The Sonara/tek device can be used during surgery to support Transcranial Doppler

Monitoring, Carotid Monitoring, Emboli Detection (HITS).

No associated transducer probes are applied invasively.

Prescription Use (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __

$$\varepsilon \text{-3}$$

Page 210

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#### Appendix F

## 2 MHz PW Hand-Held Transducer

#### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | X | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | X | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | X | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | X | | | | | | | |
| Adult Cephalic | | | X | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | X | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Intraoperative: Noninvasive use during surgery to support Transcranial Doppler Additional Comments:_

Monitoring, Carotid Monitoring, Emboli Detection (HITS).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division S Division of Reproductive, Abd and Radiological Devices F-3 10(k) Number

Page 211

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#### Appendix F

# 2 MHz PW Monitoring Transducer

### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|------------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | X | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | X | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pedialric | | | X | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | X | | | | | | | |
| Adult Cephalic | | | X | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | X | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | |

Additional Comments: Intraoperative: Noninvasive use during surgery to support Transcranial Doppler

Monitoring, Carotid Monitoring, Emboli Detection (HITS)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Danay Shrodon

Division Slar of Reproductive. liological Devices 510(k) Numbe --3

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## 4 MHz Transducer

Appendix F

#### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | X | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | X | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | X | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | X | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

#### Additional Comments:_

Prescription Use (Per 21 CFR 801.109)

Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Broadon

Division S Division of Active, Abdominal, and Radiological Devices 510/k) Number

F-3

Page 213

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## 8 MHz Transducer

Appendix F

#### Diagnostic Ultrasound Indications for Use Form

### Fill out one form for each ultrasound system and each transducer.

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | X | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | X | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | X | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | X | X | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancyc brogdon

(Division Sign-Off) Division of Reproductive, Al ominal and Radiological Device 510(k) Number ....

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