V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER

K052021 · Siemens Medical Solutions USA, Inc. · ITX · Aug 17, 2005 · Radiology

Device Facts

• Record ID: K052021
• Device Name: V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: ITX · Radiology
• Decision Date: Aug 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

V5M trans-esophageal echocardiograph (TEE) ultrasound transducer and MPT7-4 multiplane trans-esophageal echocardiograph (TEE) ultrasound transducer are intended primarily for cardiology applications. ACUSON Sequoia™ Ultrasound System is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostatc), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. ACUSON Cypress™ Ultrasound System is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. ACUSON CV70™ Cardiovascular System is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intracascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. SONOLINE G60S™ Ultrasound System is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

V5M and MPT7-4 are transesophageal echocardiograph (TEE) ultrasound transducers; consist of gastroscope control housing, flexible guide tube, and acoustic array nosepiece. Acoustic array (64 elements) rotates 180 degrees for transverse to inverse transverse imaging planes. Motor-driven rotation controlled by operator via switch; nosepiece articulation via vertebrae section and control wires. Used in clinical settings (e.g., cardiology) by trained clinicians. Provides ultrasound images and fluid flow analysis for anatomical measurement and clinical diagnosis. Benefits include visualization of cardiac structures and hemodynamics via transesophageal approach. Operates with compatible Siemens ultrasound systems (Sequoia, Cypress, CV70, G60S).

Clinical Evidence

Bench testing only. Compliance with safety and performance standards (UL, CSA, AIUM/NEMA, ISO 10993) demonstrated. No clinical data provided.

Technological Characteristics

64-element acoustic array; motor-driven 180-degree rotation; manual nosepiece articulation via control wires. Connectivity: System-specific cable/connector. Standards: UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3, ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in cardiology and general imaging applications, including fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, and musculoskeletal applications.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• V5M TEE transducer (K051139)
• V5M TEE transducer (K042055)
• V5M TEE transducer (K042770)
• MPT7-4 TEE transducer (K040060)

Submission Summary (Full Text)

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K05 2021/

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AUG 1 7 2005

Siemens Medical Solutions USA, Inc. Ultrasound Division

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V5M TEE & MPT7-4 TEE ultrasound transducers Special 510 (k): Device Modification

# SECTION 11

# 510(k) Summary of Safety and Effectiveness

| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------|
|----------|--------------------------------------------------------------------------------------------------------------------------------------------|

| Contact Person: | Iskra Mraković |
|-----------------|-----------------------------|
| | Manager, Regulatory Affairs |
| Telephone: | [phone] |
| Fax: | [phone] |

Submission Date: July 25, 2005

| Device Name: | V5Ms Transesophageal Transducer |
|--------------|----------------------------------------------|
| | MPT7-4 Multiplane Transesophageal Transducer |

Common Name: Diagnostic Ultrasound Transducers

### Classification:

Regulatory Class: II Review Category: Tier II Classification Panel: Radiology

| 21 CFR 892.1550 | | |
|----------------------------------|----------|--------------|
| | FR # | Product Code |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

### Predicate Devices:

V5M TEE transducer has already been cleared on the following ACUSON ultrasound platforms:

- ACUSON Sequoia™ ultrasound system (#K051139) ●
- ACUSON Cypress™ ultrasound system (#K042055) .
- ACUSON CV70™ cardiovascular systems (#K042770) .

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Siemens Medical Solutions USA, Inc. Ultrasound Division

MPT7-4 TEE transducer has already been cleared on the following SONOLINE ultrasound platform:

- SONOLINE G60STM ultrasound system (#K040060) .
### Device Description:

The V5M/MPT7-4 transducers consist of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.

### Intended Use:

- 1. V5M trans-esophageal echocardiograph (TEE) ultrasound transducer and MPT7-4 multiplane trans-esophageal echocardiograph (TEE) ultrasound transducer are intended primarily for cardiology applications.
- 1.1. ACUSON Sequoia™ Ultrasound System is intended for use in the following applications:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostatc), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

- 1.2 ACUSON Cypress™ Ultrasound System is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal,

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Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

#### ACUSON CV70™ Cardiovascular System is intended for the following 1.3 applications:

Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intracascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

#### SONOLINE G60S™ Ultrasound System is intended for the following 1.4 applications:

Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Sequoia Ultrasound System, the Cypress Ultrasound System, the CV70 Cardiovascular System, and the G60S Ultrasound System have been designed to conform to the following product safety standards:

- UL 2601-1, Safety Requirements for Medical Equipment ●
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic ● Ultrasound
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive .
- Safety and EMC Requirements for Medical Equipment .

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Siemens Medical Solutions USA, Inc. Ultrasound Division

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- EN 60601-1-1 .
- EN 60601-1-2 .
- EN 60601-1-37 .
- ISO 10993-1, Biological Evaluation of Medical Devices -- Part 1: Evaluation and ● Testing

The systems' acoustic output is in accordance with ALARA principle (as low as reasonably achievable)

#### Technological Comparison to Predicate Devices:

V5M TEE ultrasound transducer is substantially equivalent in its technology and functionality to the V5M TEE transducer which is already cleared under the following 510(k) premarket notification numbers: K051139 (ACUSON Sequoia ultrasound system), K042055 (ACUSON Cypress ultrasound system), and K042770 (ACUSON CV70 cardiovascular system).

MPT7-4 TEE ultrasound transducer is substantially equivalent its technology and functionality to the MPT7-4 TEE that is already cleared under the following 510(k) premarket notification number: K040060 (SONOLINE G60S ultrasound system).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, with flowing lines representing movement or connection.

Public Health Service

AUG 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Iskra Mraković Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K052021

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R032021
Trade Name: V5Ms Transesophageal Transducer and MPT7-4 Multiplane Transesophageal Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 25, 2005 Received: July 29, 2005

Dear Ms. Mraković:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion stylined 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 Increate commerce probles 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 I cuclar I ood, Drug, and Oosmons of the Act. The general controls provisions of the Act include the general connois pro risens sion, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the MPT7-4 Multiplane This determination of Substantial veques and with the SONOLINE G60 S Ultrasound System Transesophageal Transesophageal Transducer intended for use with the ACUSON CV70 and the V Stils Transcophiagon Sequoia Diagnostic Ultrasound System, and ACUSON Cypress Ultrasound System as described in your premarket notification.

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 it may be subject to sach ademal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mraković

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reasone a determination that your device complies with other requirements of the Act inal I Drederal statutes and regulations administered by other Federal agencies. You must or any I odoral 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 forth in the quant) of events (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C. Brogdon

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

Enclosure(s)

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# Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

MPT7-4 Multiplane Transesophageal Transducer for use with: SONOLINE G60 S Ultrasound System

Intended Use:

SONOEIND 000 5 criticid 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<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,7 |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Nancy bro
BASE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

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# Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

V5Ms Transesophageal Transducer for use with: ACUSON CV70 Cardiovascular System 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<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | P | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

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

> > Prescription Use (Per 21 CFR 801.109)

Nancy brogdon
(Division Sign-Off)

Division of Reproductive, and Radiological Device 5 (O(k) Number __

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## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

V5Ms Transesophageal Transducer for use with ACUSON Sequoia

## Diagnostic Ultrasound System

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

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D |
|-----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophtalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | P |
| Small Organ<br>(Specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | P | P | P | P | P | | P* | P | P |
| Trans-esophageal | | | P | P | P | P | P | | P* | P | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial<br>Other (specify)*** | | | | | | | | | | | |

P=Previously cleared by the FDA under premarket notification K051139, K032114, K022567, K002807, and K973767.

### Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+PWD+ Color Doppler, B+CWD+ Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE _________________________________________________________________________________________________________________________________________________________________

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

Prescription Use (Per 21 CFR 801.109)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomin and Dadiological Devices

DITAK, Number

Indications for Use Form

Section 6

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## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

| Device Name: | V5Ms Transesophageal Transducer for use with ACUSON Cypress<br>Ultrasound System |
|--------------|----------------------------------------------------------------------------------|
|--------------|----------------------------------------------------------------------------------|

Intended Use:

Diagnostic 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<br>(Note 1) | | P | P | P | P | P | P | | | Note 3 |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | | Note 3,4 |
| Transesophageal | | P | P | P | P | P | P | | | Note 3,4 |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Note l For example: cardiac

Harmonic imaging Note 3

Note 4 Contrast agent imaging

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

> > Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
Prescription U

(Division Sign Division of Reprodu ive Ah and Radiological Device 510(k) Number