SONIX MDP ULTRASOUND SCANNER

K080935 · Ultrasonix Medical Corporation · IYN · Aug 6, 2008 · Radiology

Device Facts

• Record ID: K080935
• Device Name: SONIX MDP ULTRASOUND SCANNER
• Applicant: Ultrasonix Medical Corporation
• Product Code: IYN · Radiology
• Decision Date: Aug 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Device Story

Diagnostic ultrasound system; utilizes transducers applied to patient to transmit ultrasound waves into body; receives echoes; processes signals to generate images on display. Used in clinical settings by physicians/clinicians for imaging and fluid flow analysis. Provides measurement and calculation packages for anatomical structures (fetal, abdominal, cardiac, etc.) to assist clinical diagnosis. Output used adjunctively with other medical data. Benefits include non-invasive visualization of internal structures and guidance for procedures like biopsies, nerve blocks, and line placement.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by performance testing, acoustic output measurements, and comparison of indications for use and technological characteristics to predicate devices.

Technological Characteristics

Diagnostic ultrasound imaging system; supports B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Directional Power Doppler modes. Transducers include phased array, convex, microconvex endocavity, and linear arrays. Connectivity and software-based processing for image reconstruction and measurement calculations. System operates via standard ultrasound pulse-echo principles.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring Ophthalmic, Abdominal, Cardiac, Intraoperative, Neurological, Fetal, Pediatric, Small Parts, Neonatal/Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal, Pelvic, Nerve Block, or Vascular Access assessment. Contraindications not specified.

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

• SonoSite MicroMaxx High Resolution Ultrsound System (K053069)
• Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326)
• SONIX Ultrasound Scanner (K061827)
• Philips HD 11 Diagnostic Ultrasound System (K062247)
• GE Logiq P5 and A5 (K060993)

Submission Summary (Full Text)

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K080935
AUG - 6 2008

# 510 (k) Summary for the Sonix MDP Ultrasound Scanner

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary.

# 1.0 Submitter Information

## 1.1 Submitter

Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-437-9500 (f) 604-437-9502

# 1.2 Contact

Chas Yu Quality Assurance Manager Tel. [phone] ext 152 Fax. [phone] Email: [e-mail]

# 1.3 Date Prepared

April 1, 2008

### 2.0 Device Name

# 2.1 Common Name

Ultrasound Imaging System

## 2.2 Proprietary Name

Sonix MDP Ultrasound Scanner

### 2.3 Classification Name

| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

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# 2.4 Classification

Class II

# 2.5 Predicate Device:

SonoSite MicroMaxx High Resolution Ultrsound System (K053069) Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993)

# 2.6 Reason for submission:

# Name change request

N/A

# New product clearance for:

| SONIX MDP Ultrasound Scanner and Transducers: | L14-5/38<br>C5-2/60<br>EC9-5/10<br>SA4-2/24 |
|-----------------------------------------------|---------------------------------------------|
|-----------------------------------------------|---------------------------------------------|

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a bird in flight or flowing ribbons.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chas Yu Quality Assurance Manager Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, BC, V6V 2K9 CANADA

AUG - 6 2008

Re: K080935

Trade/Device Name: SONIX MDP Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 10, 2008 Received: June 19, 2008

Dear Mr. Yu:

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 SONIX MDP Ultrasound System, as described in your premarket notification: .

Transducer Model Number

# SA/24mm Phased Array 2.8 MHz C5-2/60 Convex 3.2 MHz 60mm Radius EC9-5/10 Microconvex Endocavity 6.6 MHz 10mm Radius L14-5/38 Linear 8 MHz 38mm

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

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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 promincntly marked "ADD-TO-FILE" and should be submitted in duplicate to:

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours.

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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# Indications for Use

510(k) Number (if known): K080935

Device Name: SONIX MDP Ultrasound System

Indications For Use:

The SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access.

The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SONIX MDP Ultrasound System indication(s) for use are the same as the predicate devices. Please see attached IFU comparison chart between SONIX MDP and the predicate devices.

The ultrasound plateform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into human body. The system then receives echoes back from human body, processes them to yield an image on a display.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of 1

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# ULTRASOUND INDICATIONS FOR USE TABLES

#### SONIX MDP Ultrasound Scanner – Diagnostic Ultrasound Indications for Use Form

Intended use:

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

| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Abdominal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Intraoperative (specify) | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Intraoperative Neurological | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Pediatric | N | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Small Organ (specify) | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Neonatal Cephalic | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Adult Cephalic | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Cardiac | N | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Transesophageal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Transrectal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Transvaginal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Laparoscopic | | | | | | | | | | | |
| MSK Conventional | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| MSK Superficial | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Vascular Access | N | N | N | N | | N | N | N | N (*1) | N (*2, *4) | |
| Nerve Block | N | N | N | N | | N | N | N | N (*1) | N (*2, *3) | |
| Other (specify) | | | | | | | | | | | |

### N = New indication; P = Previously cleared

### Additional Comments:

Small Organ: Breast, Thyroid, Testicle

Intraoperative: Abdominal organs and vascular

- *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- Directional Power Doppler (DPD), Imaging for guidance of biopsy *2.
-
- 2. Oneonomic for guidance of nerve block injections
*4. I maging for guidance of central or peripheral lines.

| SONIX MDP User Manual | |
|-----------------------|--|
|-----------------------|--|

00.040.051, Revision A

Appendix C: Transdcuer Specifications

Hulda Reimer

1

(Division Sign-Off) Division of Reproductive, Abdomina Radiological D 510(k) Number

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### Diagnostic ULTRASOUND INDICATIONS FOR USE Form SA/24mm phased array 2.8 MHz 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>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatai Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Vascular Access | | | | | | | | | | |
| Nerve Block | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

- *1. B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Directional Power Doppier (DPD)
2. Directional Power Doppler (DPD)

Appendix C: Transdcuer Specifications

00.040.051, Revision A

SONIX MDP User Manual

2

Hulu Lesem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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### Diagnostic ULTRASOUND INDICATIONS FOR USE Form Č5-2/60 convex 3.2 MHz 60mm radius transducer

### Intended use:

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

| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Abdominal | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Small Organ (specify) | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Neonata! Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Laparoscopic | | | | | | | | | | | |
| MSK Conventional | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| MSK Superficial | N | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Vascular Access | | | | | | | | | | | |
| Nerve Block | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

Small Organ: Breast, Thyroid, Testicle

- *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DFD/CWD
*2. Directional Power Doppler (DPD), Imaging for guidance of biopsy
2. Directional Power Doppler (DPD), imaging for guidance of biopsy

| SONIX MDP User Manual | 00.040.051, Revision A | Appendix C: Transdcuer Specifications |
|-----------------------|------------------------|---------------------------------------|
| | 3 | |

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices

| 510(k) Number | K080935 |
|---------------|---------|
|---------------|---------|

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### Diagnostic ULTRASOUND INDICATIONS FOR USE Form EC9-5/10 microconvex endocavity 6.6 MHz 10mm radius transducer

### Intended use:

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Transvaginal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Vascular Access | | | | | | | | | | |
| Nerve Block | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = New indication; P = Previously cleared

Additional Comments:

*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/D/CV/D, B/DPD/CWD

*2. Directional Power Doppler (DPD), Imaging for guidance of biopsy

| Appendix C: Transdcuer Specifications | 00.040.051, Revision A | SONIX MDP User Manual |
|-----------------------------------------|------------------------|-----------------------|
| | 4 | |
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal and | | |
| Radiological Devices | | |
| 510(k) Number | 2080935 | |

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### Diagnostic ULTRASOUND INDICATIONS FOR USE Form L14-5/38 linear 8 MHz 38mm transducer

### Intended use:

# Diagnostic uitrasound 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>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) |
| MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Vascular Access | | N | N | N | | N | N | N | N (*1) | N (*2, *4) |
| Nerve Block | | N | N | N | | N | N | N | N (*1) | N (*2, *3) |
| Other (specify) | | | | | | | | | | |

#### N = New indication; P = Previously cleared

### Additional Comments:

Small Organ: Breast, Thyroid, Testicle

- *1. B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/OPD/PWD, B/OFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Directional Power Dopbler (DPD), Imaging for guidance of biopsy
*3. Imaging for guidan
*2. Directional Power Doppler (DPD), Imaging for guidance of biops

-
- *4. Imaging for guidance of central or peripheral lines.

00.040.051, Revision A

5

Appendix C: Transdcuer Specifications

Hecho Leuer

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