MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION

K063184 · Toshiba America Medical Systems, In.C · JAK · Nov 3, 2006 · Radiology

Device Facts

• Record ID: K063184
• Device Name: MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAK · Radiology
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

CVV-001A, Vessel View Software is a post processing software option for the TSX-101A CT system. This product can be used for the analysis of CT angiography images. It provides display and measurement tools that can aid trained physicians for visualizing and assessing various blood vessels.

Device Story

CVV-001A is a post-processing software option for the TSX-101A Aquilion CT system. It takes CT angiography images as input; provides visualization and measurement tools for blood vessel assessment. Operated by trained physicians in a clinical setting; output is displayed on the system monitor to aid in clinical decision-making regarding vascular assessment. The device facilitates the analysis of blood vessels through automated or manual measurement tools.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based post-processing package for the TSX-101A CT system. Provides visualization and measurement tools for CT angiography. Operates as an integrated software option on the existing CT platform. No specific hardware materials or energy sources are applicable as this is a software-only modification.

Indications for Use

Indicated for trained physicians to visualize and assess blood vessels using CT angiography images acquired on the TSX-101A CT system.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GE CardIQ Analysis II (k020796)

Submission Summary (Full Text)

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# 063184

### 510(k) Summary

#### NOV - 3 2006

| Date: | September 8, 2006 |
|---------------------------------------|--------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact:<br>[phone] | Paul Biggins, Regulatory Affairs Specialist, |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | CVV-001A, Vessel View Software |
| Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code:<br>90JAK] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard:<br>Standard | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment |
| Predicate Device(s): | GE CardIQ Analysis II; k020796 |
| Reason For Submission | Modification of cleared device |

#### Description of this Device:

The CVV-001A will be added to the previously cleared TSX-101A Aquilion CT system. This addition requires software modifications to the existing device. Addition of this option will provide trained physicians with visualization and measurements tools for assessing blood vessels.

#### Summary of Intended Uses:

CVV-001A is designed to facilitate the assessment of blood vessels by a trained physician in that it provides display and measurements tools.

#### Technological Characteristics:

This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Toshiba America Medical Systems, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313

NOV - 3 2006

,

Re: K063184

Trade/Device Name: CVV-001A, Vessel View Software Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 16, 2006 Received: October 20, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootton 910(t) prochantially equivalent (for the indications for relered above and nave acteriminar arketed predicate devices marketed in interstate commerce use stated in the enotosure) that of the Medical Device Amendments, or to devices that prior to May 20, 1770, and client date the provisions of the Federal Food, Drug, and Cosmetic have been roclassified in acceration of a premarket approval application (PMA). You may, Act (Act) market the device, subject to the general controls provisions of the Act. The general therefore, mainer the device, subject to an generation, listing of devices, good controls provisions or and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket tt your device is classified (bod as a very atitional controls. Existing major regulations affecting your Apploval), it thay be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the federal Register.

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Protecting and Promoting Public Se

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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.

Sincerely yours,

Nancy C Hodgdon

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

Enclosure

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## Indications for Use

510(k) Number (if known): Қоб 318 Ч

Device Name: CVV-001A, Vessel View Software

Indications For Use:

CVV-001A, Vessel View Software is a post processing software option for the TSX-101A CT system. This product can be used for the analysis of CT angiography images. It provides display and measurement tools that can aid trained physicians for visualizing and assessing various blood vessels.

Prescription Use 1 (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)

Nancy C. Broadlon
(Division Sign-Off)

ductive, Abdom ological Devices

510(k) Number K063

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