PIONEER TC8080, COMPANION III

K053648 · Viasys Neuro Care · IYN · Jan 24, 2006 · Radiology

Device Facts

• Record ID: K053648
• Device Name: PIONEER TC8080, COMPANION III
• Applicant: Viasys Neuro Care
• Product Code: IYN · Radiology
• Decision Date: Jan 24, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The modified Pioneer TC8080 and Companion III are applied to indicate blood flow by application of Doppler ultrasound technology. Reference the accompanying Indication for Use Forms.

Device Story

Pioneer TC8080 and Companion III are Doppler ultrasound systems for blood flow detection. Systems utilize Doppler shift principle: ultrasound probe transmits ultrasonic energy into body; reflected energy from moving blood is detected as frequency-shifted signal. Amount of frequency shift correlates to blood flow velocity. Systems process and display Doppler signals. Pioneer TC8080 supports up to four probes; Companion III supports up to two. Used in clinical settings for monitoring blood flow (e.g., transcranial, carotid, microvascular). Healthcare providers use output to assess vascular status and detect emboli. Benefits include non-invasive, real-time hemodynamic monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by technical specifications and acoustic output measurements consistent with previously cleared diagnostic ultrasound systems.

Technological Characteristics

Doppler ultrasound system using pulsed wave (PW) and continuous wave (CW) modes. Probes: 1.6 MHz (PW), 2 MHz (PW), 4 MHz (PW/CW), 8 MHz (PW/CW), 16 MHz (PW), 20 MHz (PW). Probes are unfocussed and non-implantable. Connectivity: Multi-probe support. Software-based signal processing for Doppler shift analysis.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis. Patient populations include ophthalmic, intraoperative (neurological, microvascular), pediatric, neonatal cephalic, adult cephalic, and peripheral vascular applications. Specific clinical uses include transcranial/intracranial Doppler monitoring, carotid monitoring, emboli detection, and microvascular blood flow assessment. Prescription use only.

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

• EME TC2-64B (K864695)
• Pioneer TC8080 (K020754)
• HDI 5000 Ultrasound System (K011224)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for VIASYS Healthcare. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "Excellence For Life" in a smaller, italicized font.

NEUROCARE GROUP

Nicolet Riomedical • GM • Nicolet Vascular

# 510(k) Summary

JAN 2 4 2006

| Company Name: | VIASYS NEUROCARE<br>5225 Verona Road<br>Madison, WI 53711 |
|----------------------|--------------------------------------------------------------------------|
| Contact: | Glen Hermanson, Global Manager, Quality Engineering |
| Phone: | 608 441-2065 |
| Fax: | 608 441-2007 |
| Summary Date: | December 27, 2005 |
| Trade Name: | Pioneer TC8080, Companion III |
| Common Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Name: | 21 CFR 882.1550: Product Code: IYN<br>21 CFR 892.1579; Product Code: ITX |
| Predicate Device(s): | |
| | 510(k) Number: K864695 |
| | Manufacture: EME |
| | Trade Name: EME TC2-64B |
| | 510(k) Number: K020754 |
| | Manufacture: Nicolet Biomedical |
| | Trade Name: Pioneer TC8080 |
| | 510(k) Number: K011224 |
| | Manufacture: Advanced Technology Laboratories. Inc. |
| | Trade Name: HDI* 5000 Ultrasound System |

#### Description of Device 1 .()

The modified Pioneer TC 8080 and Companion III are Doppler ultrasound systems. Both systems utilize the well-understood principle of Doppler shift to detect the flow of blood within the body. The ultrasound probe generates ultrasonic energy, which is coupled to the body. The ultrasonic energy, which is reflected from the moving blood in blood vessels and

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K053649
PRY 2 of 2

the returning signal, is detected as a frequency shifted signal. The amount of frequency shift is a function of the velocity of the flowing blood. These systems generate, transmit and receive an ultrasonic signal, then process and display the Doppler signal returning from the anatomy.

The Pioneer TC8080 can be used with up to four Doppler ultrasound probes simultaneously. The Companion III, applying the same software and hardware as the Pioneer TC8080, can be used with up to two Doppler ultrasound probes simultaneously.

#### 2.0 Intended Use

The modified Pioneer TC8080 and Companion III are applied to indicate blood flow by application of Doppler ultrasound technology. Reference the accompanying Indication for Use Forms.

#### 3.0 Technological

Doppler ultrasound probes with a variety of modes of operation are available for use with the systems. The 1.6 MHz probe is an unfocussed pulsed wave Doppler probe (PW). The 2 MHz probes (15-mm diameter and 10 mm diameter) are unfocussed PW Doppler probes. The 4 MHz and 8 MHz probes are unfocussed probes that operate in continuous wave (CW) or PW Doppler mode. The 16 MHz and 20 MHz Microvascular probes (1.5 mm and 2.0 mm diameter) are unfocussed PW Doppler probes. The ultrasound probes do not directly contact the blood and are not implantable.

#### 4.0 Conclusions

:

The indications, intended use and technology of the modified Pioneer TC8080 and Companion III devices are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services (USA). The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle's head and neck, composed of three curved lines.

JAN 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Viasys Neurocare % Mr. Gary Syring Principle Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane STOUGHTON WI 53589

Re: K053648

Trade Name: Pioneer TC8080 / Companion III Doppler Ultrasound 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: December 27, 2005 Received: December 30, 2005

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 Pioneer TC8080 / Companion III Doppler Ultrasound Systems, as described in your premarket notification:

Image /page/2/Picture/11 description: The image shows the FDA Centennial logo. The logo is a circular seal with the letters "FDA" in the center. The words "Centennial" are below the letters. The text "Protecting and Promoting Public Health" is below the logo.

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## Transducer Model Number

1.6 MHz Probe 2 MHz Probe 4 MHz Probe 8 MHz Probe 16 MHz Probe 20 MHz Probe

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

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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

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C Bigdon

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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Pioneer TC 8080

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Appendix F

### Diagnostic Ultrasound Indications for Use Form

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

Intended Use: Diagnostic uttrasound imaging or fluid flow anaiysis 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 | | | | N | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | N | | | | | | | |
| Intraoperative Neurological | | | | N | | | | | | | |
| Pediatric | | | | N | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | N | | | | | | | |
| Adult Cephalic | | | | P | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | P | P | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>Additional Comments: P = Cleared to market by 510(k) K020754<br>The Pioneer TC8080 applies ultrasound probes of 1.6 MHz Pulsed Wave (PW).<br>2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz PW/CW. | | | | | | | | | | | |
| 16 MHz PW and 20 MHz PW. Intraoperative: Transcranial and Intracranial Doppler<br>Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection. | | | | | | | | | | | |
| | | | | | | | (PLEASE DO NOT WRITE BELOW THIS LINE ) CONTINUE ON ANOTHER PAGE (IF NEEDED)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
| Prescription Use (Per 21 CFR 801 109) | | | | | F-3 | | | | | | |
| (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>and Radiological Devices<br>510(k) Number | | | | | | | | | | | |

..... . . . .

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Companion HI

.

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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 | A | B | M | | PWD CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|---|---|---------|------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------|--------------------|
| | Ophthalmic | | | | N | | | | | | |
| | Fetal | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intraoperative (specify) | | | | N | | | | | | |
| | Intraoperative Neurological | | | | N | | | | | | |
| | Pediatric | | | | N | | | | | | |
| | Small Organ (specify) | | | | | | | | | | |
| | Neonatal Cephalic | | | | N | | | | | | |
| | Adult Cephalic | | | | F | | | | | | |
| | Cardiac | | | | | | | | | | |
| | Transesophageal | | | | | | | | | | |
| | Transrectal | | | | | | | | | | |
| | Transvaginal | | | | | | | | | | |
| | Transurethral | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Peripheral Vascular | | | | E | E | | | | | |
| | 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: E – Cleared to market by 510(k) K020754 as a non-significant change to | | | | | | | | | | |
| | The Pioneer TC8080. The Companion III applies ultrasound probes of 1.6 MHz Pulsed Wave | | | | | | | | | | |
| | | | | | | | | | | | |
| | 2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz PW/CW, | | | | | | | | | | |
| | 16 MHz PW and 20 MHz PW. Intraoperative: Transcranial and Intracranial Doppler<br>Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection. | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | Prescription Use (Per 21 CFR 801 109) | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | 1-3 | | | | | |
| (Division Sign | | | | | | | | | | | |
| Division of Re | productive, Abdominal<br>and Radiological Devices | | | | | | | | | | |

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1.6 MHz Probe for Pioneer TC8080 and Companion III

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 | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | N | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | P | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |

Other (specify)

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

Additional Comments: P Cleared to market by 510(k) K020754

Intraoperative: Transcranial Doppler Monitoring, Emboli Detection.

(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)

F-3

Nancyc bradon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices K053648

510(k) Number

Page A - 4

: :

:

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...

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

(Division Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Page A - 5

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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 | 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) | | | | N | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | N | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | N | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | P | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>Additional Comments: P-Cleared to market by 510(k) K020754<br>Intraoperative: Extracranial carotid monitoring. | | | | | | | | | | |

(Division Sign-Off Division of Reproductiv and Radiological Devices 510(k) Number .

Page A - 6

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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) | | | | N | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | N | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | N | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | P | P | | | | | |
| 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: P = Cleared to market by 510(k) K020754

Intraoperative: Extracranial carotid monitoring.

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

Prescription Use (Per 21 CFR 801 109)

Nancut Snordon
F 3

(Division Sign-Off) Division of Reproductive, Abdon inal, and Radiological Devices 510(k) Number

{11}------------------------------------------------

。

------

and Radiological Devices

510(k) Number _

Appendix F

Page A - 8

### 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) | | | | N | | | | | | | |
| Intraoperative Neurological | | | | N | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>Additional Comments: P - Cleared to market by 510(k) K020754<br>Two crystal diameters are indicated: 1.5 mm diameter and 2.0 mm diameter<br>Intraoperative: Microvascular Blood Flow. | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | | | | | | | | |
| Prescription Use (Per 21 CFR 801.109) | | | | | |…