GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028

K980851 · Boston Scientific Corp · IYO · Apr 22, 1998 · Radiology

Device Facts

• Record ID: K980851
• Device Name: GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
• Applicant: Boston Scientific Corp
• Product Code: IYO · Radiology
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

Device Story

Galaxy Intravascular Ultrasound (IVUS) System; utilizes catheter-tip transducer to emit reflected ultrasound energy into interior vessel walls; captures two-dimensional images of vessel structure; used to detect abnormalities or obstructions. Operated by clinicians in interventional settings; provides real-time visualization of vessel anatomy to guide interventional procedures like angioplasty and atherectomy; aids clinical decision-making by identifying lesion characteristics and vessel morphology; benefits patients by facilitating precise procedural guidance.

Clinical Evidence

Bench testing only. Hardware and software verification and validation testing performed. Acoustic output measured and calculated per Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, 1993).

Technological Characteristics

Intravascular ultrasound imaging system; catheter-tip transducer; B-mode operation; acoustic output compliant with UD-2, Revision 1 (1993) standard; hardware and software components; system console for image processing and display.

Indications for Use

Indicated for patients undergoing transluminal interventional procedures (angioplasty, atherectomy) requiring intravascular ultrasound examination of vessel pathology.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• BSC (formerly CVIS) Insight III Imaging System (K921750) with Automatic Pullback Device (K933517) and LongView (K930311)
• EndoSonics In-Vision (Clearance number: Not available)

Submission Summary (Full Text)

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APR 22 1998

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

### Applicant Information:

| Date Prepared: | March 3, 1998 |
|----------------|----------------------------------------------------------------------------------------|
| Name: | Boston Scientific Corporation - San Jose<br>2710 Orchard Parkway<br>San Jose, CA 95134 |

Donna K. Templeman Contact Persons: Dennis L. Wong Manager, Regulatory Affairs Regulatory Affairs Associate

Telephone numbers: [phone] or [phone]

Fax number: [phone]

### Device Information:

| Classification: | Class II | |
|------------------------------------------|-----------------------------------------|--------------|
| Trade Name: | Galaxy Intravascular Ultrasound System | |
| Common Name: | Intravascular Ultrasound Imaging System | |
| Product Code: | FR Number | Product Code |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |

### Equivalent Devices:

The Galaxy Imaging System is substantially equivalent in intended use, design and / or method of operation to a combination of the following predicate devices:

- 1. BSC (formerly CVIS) Insight III Imaging System (K921750) with
- Automatic Pullback Device (K933517)
- LongView (K930311)
- 2. EndoSonics In-Vision™ (Clearance number: Not available)

Special 510(k)

Galaxy Intravascular Ultrasound Imaging System

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### Intended Use:

The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

#### Comparison To Predicate Devices:

The Galaxy Imaging System applies reflected ultrasound energy through a catheter tip transducer directly into the interior vessel wall of the patient to obtain a two dimension image of the vessel structure that can be used to detect abnormalities or obstructions. There are other ultrasound systems presently on the market with these intravascular imaging capabilities. The subject BSC Galaxy Imaging System is similar in design, function, and application to these ultrasound systems.

The Galaxy Imaging System is substantially equivalent in intended use, design and operation characteristics to the following devices: (1) BSC (formerly CVIS) Insight III Imaging System (K921750) (with Automatic Pullback Device (K933517) and LongView (K930311)), and (2) EndoSonics In-Vision™ (Clearance number: Not available). All predicate devices are used for ultrasound imaging of intravascular pathology in vessel anatomy.

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### Non-Clinical Tests:

Bench and acoustic output testing will be tested to demonstrate that the BSC Galaxy Intravascular Ultrasound Imaging System is safe and effective, while meeting the anticipated clinical requirements for its intended use.

### Bench Testina:

Bench testing, both hardware and software will undergo complete verification and validation testing.

### Acoustic Output Testing:

The BSC Galaxy Intravascular Ultrasound Imaging System will be measured and calculated per the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993), not 1997, as referenced in the FDA guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers of September 30, 1997. This is a possible deviation of the acoustic output measurement methodology at Boston Scientific from the NEMA guidance documents referred to in the FDA's guidance document.

### Rationale for Deviation

The FDA guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers of September 30, 1997 refers to the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA 1997), and specifically to its Section 3.3.2. However, it is our understanding that no 1997 standard has been published yet, and the most recent version of the NEMA standard that we have been able to obtain is the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1. December 7. 1993). The section 3.2.2 of this document does not reflect the wording of the 1997 FDA document and its reference to the 1997 NEMA standard regarding the low end of the frequency response of the hydrophone system (i.e., f./20). Also, the 1997 FDA quidance document states the following: "non-membrane (e.g., needle-type) hydrophones are acceptable for uses not directly affecting reporting or labeling, such as in quality control measurements" which is not reflected in the wording of the Section 3.2.2 in the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993).

### Summary:

There are other ultrasound systems presently on the market with intravascular imaging capabilities. The subject BSC Galaxy Imaging System is similar in design, function, and application to these ultrasound systems and is substantially equivalent to these currently marketed predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1998

Donna Templeman Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134

Re: K980851 Galaxy Intravascular Ultrasound Imaging System Dated: March 4, 1998 Received: March 5, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO

Dear Ms. Templeman:

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 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. You may, therefore, market the device, subject to the general controls The general controls provisions of the Act include provisions Act (Act). requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Galaxy Intravascular Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

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.

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#### Page 2 - Donna Templeman

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 (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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address -"http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at [phone].

Sincerely yours,

L. Elinard C. Heymann

llian Yin, Ph.D 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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510(k) Number (if known):

Galaxy Intravascular Ultrasound Imaging System Device Name:

Indication For Use:

The Galaxy Intravascular Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

K 980851

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

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

Thiel A. Segrom
(Division Sign-Off)

Division of Reproductive, Abdominal, B and Radiological Devi 510(k) Number

**Prescription Use**
**(Per 21 CFR 801.109)** OR

Over-The-Counter Use

(Optional Format 1-2-96)

March 4, 1998

0:91

BSC - San Jose

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K 980851

Special 510(k)
Galaxy Intravascular Ultrasound Imaging System

### Diagnostic Ultrasound Indications for Use Form For Galaxy System Imaging Console

### 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | N | | | | | | | | |
| 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:_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

March 4, 1998

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### Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 9F/9MHz

### 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | E | | | | | | | | |
| 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:_________________

-

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Image /page/8/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K980851'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance. The contrast between the characters and the background is clear, making the sequence easily readable.

### Diagnostic Ultrasound Indications for Use Form For Discovery 2.6F/40MHz

### 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | E | | | | | | | | |
| 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: _________________________________________________________________________________________________________________________________________________________

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

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K980851

Special 510(k) Galaxy Intravascular Ultrasound Imaging System

### Diagnostic Ultrasound Indications for Use Form For Discovery 2.6F/30MHz

### 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | E | | | | | | | | |
| 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: _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

March 40199

યું ક

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Image /page/10/Picture/0 description: The image shows the text "K980851" in a handwritten style. Below this, the text "Special 510(k)" is printed in a smaller, more formal font. The text "Galaxy Intravascular Ultrasound Imaging System" is printed below the "Special 510(k)" text.

### Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 3.2F/20MHz

#### 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | ﺍ | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | | | | | | | | |
| 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:___

-

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### Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 6F/20MHz

## 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | E | | | | | | | | |
| 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:_

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

Qra

Image /page/11/Picture/11 description: The image shows the text "March 4, 1998" on the top line and "0197" on the second line. The text is black and the background is white. The text is slightly blurry.

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

### Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 6F/12.5MHz

## 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) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | E | | | | | | | | | |
| 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:________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

J

March 409989 8

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### Diagnostic Ultrasound Indications for Use Form For UltraCross 2.9F/30MHz

### 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) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | E | | | | | | | | |
| 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:__________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

March 4,

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### Diagnostic Ultrasound Indications for Use Form For UltraCross 3.2F/30MHz

### 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) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | E | | | | | | | | | |
| 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:

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