AU6

K990360 · Biosound Esaote, Inc. · IYN · Apr 30, 1999 · Radiology

Device Facts

• Record ID: K990360
• Device Name: AU6
• Applicant: Biosound Esaote, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AU6 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

Device Story

AU6 is a diagnostic ultrasound imaging system used by physicians in clinical settings. It processes acoustic signals from various transducers (annular array, mechanical sector, linear, convex, phased array, 1.5D) to generate real-time images. Supported modes include 2D, M-mode, PW Doppler, CW Doppler, CFM (Color Flow Mapping), Power Doppler, and Triplex. The system features integrated digital storage (DSM) and connectivity. Output is displayed on a 15-inch monitor for clinical interpretation. The device aids in diagnostic assessment of cardiac, abdominal, peripheral vessel, and fetal structures. Benefits include non-invasive visualization and hemodynamic analysis to support clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of acoustic output measurements.

Technological Characteristics

Ultrasound imaging system; transducers: annular array, mechanical sector, linear, convex, phased array, 1.5D. Frequencies: 2D (2.5-15 MHz), PW (2.25-15 MHz), CW (2.25-10 MHz). Modes: 2D, M, PW/CW/CFM/Power Doppler, Triplex. Features: 15-inch monitor, 10 presets, HIPRF, integrated DSM, connectivity. Sterilization: Transducers are reusable (requires disinfection).

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in cardiac, abdominal, peripheral vascular (including vein mapping and sclerotherapy), fetal, small organ (thyroid, testicles, breast), neonatal cephalic, and intraoperative applications. 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

• Esaote AU5 (K980468)

Submission Summary (Full Text)

{0}------------------------------------------------

4/30/99

510(k) Summary AU6 Biosound Esaote

K99D360

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

# Submitter Information

Colleen Hittle, Official Correspondent
8000 Castleway Drive
Indianapolis, IN 46250

| Phone: | [phone] |
|-------------------------|---------------------------------------------|
| Facsimile: | [phone] |
| Contact Person: | Colleen Hittle |
| Date: | February 3, 1999 |
| 807.92(a)(2) | |
| Trade Name: | AU6 |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | System, Imaging, Pulsed Doppler, Ultrasonic |
| Classification Number: | 90IYN; 90IYO |
| 807.92(a)(3) | |

Predicate Device(s)

| Esaote | AU5 | K980468 |
|--------|-----|---------|
|--------|-----|---------|

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

{1}------------------------------------------------

510(k) Summary AU6 Biosound Esaote

# 807.92(a)(5)

# Intended Use(s)

The AU6 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

{2}------------------------------------------------

| General Characteristics | Esaote | Esaote |
|-------------------------|--------------------|---------------------|
| | AU5 (K#980468) | AU6 Digital |
| Transducer Type | Annular Array | Annular Array |
| | Mechanical Sector | Mechanical Sector |
| | Linear | Linear |
| | Convex | Convex |
| | Phased Array | Phased Array |
| | NO | 1.5D |
| 2D Freq MHz | 2.5/15 | 2.5/15 |
| PW Freq MHz | 2.25/10 | 2.25/15 |
| CW Freq MHz | 2.25/5.0 | 2.25/10 |
| 1.5 D | NO | 3.5/10 |
| Imaging Modes | Real-time/2D | Real-time/2D |
| | M Mode | M Mode |
| | PW Doppler | PW Doppler |
| | CW Doppler | CW Doppler |
| | CFM Doppler | CFM Doppler |
| | Power Doppler | Power Doppler |
| | Triplex | Triplex |
| Probes MHz | | |
| Annular Array | 10-20 | 20 |
| Linear | 5.0-13 | 5.0-10.0 |
| Convex | 3.5-7.5 | 3.5-5.0 |
| Phased Array | 2.5-3.5 | 2.5-10 |
| 1.5 D | NO | 3.5-10 |
| Multifreqency probes | Yes | Yes |
| Special probes | IVT transvaginal | IVT transvaginal |
| | TRT transrectal | TRT transrectal |
| | | TEE transesophageal |
| | LP laparoscopic | LP laparoscopic |
| | IOE intraoperative | IOE intraoperative |
| Biopsy attachments | Convex | Convex |
| | Linear | Linear |
| Monitor size (inches) | 14 | 15 |
| Programmability | 6 presets | 10 presets |
| Pulsed/CW Doppler | Yes | Yes |
| HIPRF | No | Yes |
| 2D Updating | Yes | Yes |
| CW steerable | Yes | Yes |
| Audio stereo | Yes | Yes |
| Color Doppler upgrade | Yes | Yes |
| ECG | Option | Option |
| Interconnectivity | NO | YES |
| DSM integrated | YES | YES |

540 mm

690 mm

-height

-depth

# Comparison Chart for Substantial Equivalence

1440 mm 1100 mm Page 5

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1999

Colleen J. Hittle The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250

Re: K990360 AU6 Diagnostic Ultrasound System Dated: April 9, 1999 Received: April 9, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN

Dear Ms. Hittle:

We have reviewed your Section 510(k) 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 AU6 Diagnostic Ultrasound System as described in your premarket notification:

| Transducer Model Number | |
|-------------------------|--------|
| CA11 | IOE13A |
| LA13A | LP13A |
| IVT22 | TRT12 |
| SMA50 | PA11B |
| TEE 22 | PT10A |
| P10A | |

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page -2 - Ms. Hittle:

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

{5}------------------------------------------------

Page -- 3 -- Ms. Hittle

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

Sincerely yours,

David A. Segerson

for

CAPT Daniel B. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Conc ence of CDRH. Office of Device Evaluation (ODE)

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

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{7}------------------------------------------------

# 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:

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

Additional Comments: Applicable combined modes: B+PW+CFM+M+PD

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David le. Glavon Prescription Use **__**
(Per 21 CFR 801.109)

{8}------------------------------------------------

# 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 | | | | | | | | Combined (specify) | Other (specify) | |
|------------------------------------------------------------|-------------------|---|---|-----|-----|-------------------------|----------------------------|------------------------------|-----------------------|------------------------|--|
| | A | B | M | PWD | CWD | Color Doppler CFM | Amplitude Doppler PD | Color Velocity Imaging | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) Abdominal | | P | P | P | | | P | P | | See comments | |
| Intraoperative (specify) Peripheral vascular | | E | E | E | | | E | E | | See comments | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | E | E | E | | | E | E | | See comments | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | | P | P | | See comments | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify)<br>Peripheral vascular | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | P | P | P | P | | P | P | | See<br>comments | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | E | E | E | | E | E | | See<br>comments | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | | |
| Laparoscopic | | P | P | P | | P | P | | See<br>comments | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify<br>) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | See<br>comments | | |
| Transvaginal | | N | N | N | | N | N | | See<br>comments | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other-Urological | | N | N | N | | N | N | | See<br>comments | | |
| Mode of Operation | | | | | | | | | | | |
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | E | E | E | | E | E | | See<br>comments | | |
| Transvaginal | | P | P | P | | P | P | | See<br>comments | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other-Urological | | N | N | N | | N | N | | See<br>comments | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | P | P | | | | | | See<br>comments | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | E | E | | | | | | See<br>comments | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | See<br>comments | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | See<br>comments | | |
| Adult Cephalic | | N | N | N | N | N | N | | See<br>comments | | |
| Cardiac | | N | N | N | N | N | N | | See<br>comments | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric<br>Small Organ<br>(specify)<br>Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Tranesophageal | | N | N | N | N | N | N | | See<br>Comments | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional<br>Musculo-skeletal | | | | | | | | | | | |
| Superficial<br>Other | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | P | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | E | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>CFM | Amplitude<br>Doppler<br>PD | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | P | | | | | | |
| Tranesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | E | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |

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

Additional Comments: Small organs (specifically, thyroid, testicles and breast; Peripheral vascular to include Vein Mapping & Scierotherapy

Applicable combined modes: B+PW+CFM+M+PD

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

| Prescription Use<br>(Per 21 CFR 801.109) | Concurrence of CDRH, Office of Device Evaluation (ODE) | K990360 |
|------------------------------------------|--------------------------------------------------------|---------|
|------------------------------------------|--------------------------------------------------------|---------|

14

{9}------------------------------------------------

AppendixF

### 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:

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

Additional Comments: Small Organs (specifically, thyroid, testicles, and beast): Peripheral Vascular to include. Vein Mapping &
Sclerotheragy

Applicable combined modes: B+PW+CFM+M+PD

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | K990360 |
|--------------------------------------------------------|---------|
| Prescription Use<br>(Per 21 CFR 801.109) | |

15

{10}------------------------------------------------

# 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:

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

Additional Comments: Applicable combined modes: B+PW+CFM+M+PD

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

ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

૧૯

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

# 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:

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

Additional Comments: Applicable combined modes: B+PW+CFM+M+PD

(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) | |

Lezama

{12}------------------------------------------------

### Appendix F

# TRT12

# 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:

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

Additional Comments: Applicable combined modes: B+PW+CFM+M+PD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 90360

i

**Concurrence of CDRH, Office of Device Evaluation (ODE)**

Prescription Use (Per 21 CFR 801.109)

{13}------------------------------------------------

### 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:

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

Additional Comments: Small Organs (specifically, thyroid testicles, and beast): Perigheral vascular to include Yein Mapping & 2018/08/19997

Applicable combined modes: B + M

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Preser (Per 21 CFF R 801.109)

David A. Szezin 19

{14}------------------------------------------------

# PA11B

# 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:

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

Additional Comments: : Applicable combined modes: B+PW+CW+CFM+M+PD

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

DE) K990360

- Quind C. Segerson

escription ofe
21 CFR 801.109)

{15}------------------------------------------------

### 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:

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

Additional Comments: Applicable combined modes: B+PW+CFM+M+PD+CW

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K99036D

Prescription Use
(Per 21 CFR 801.109) ✓

Daniel A. Szyrm

{16}------------------------------------------------

PT10A

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:

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

Additional Comments:_

(PLEASE DO NOT WRITE BE…