MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205

K993598 · Vidar Systems Corp. · LMA · Jan 20, 2000 · Radiology

Device Facts

• Record ID: K993598
• Device Name: MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
• Applicant: Vidar Systems Corp.
• Product Code: LMA · Radiology
• Decision Date: Jan 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The intended use of the MAMMOGRAPHY PRO and Diagnostic PRO-M is to produce digital copies of medical x-ray films. The MAMMOGRAPHY PRO and Diagnostic PRO-M are indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.

Device Story

The MAMMOGRAPHY PRO and Diagnostic PRO-M are x-ray film digitizers; they convert analog medical x-ray films into digital images. The device is used in clinical settings to facilitate the review and analysis of mammographic images by healthcare professionals. The output is a digital representation of the original film, which clinicians use to support diagnostic workflows. The device is not intended to serve as the sole basis for screening or diagnosis, but rather as an aid in the clinical evaluation process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic x-ray film digitizer; converts analog film to digital images. Class II device per 21 CFR 892.2030/90 LMA.

Indications for Use

Indicated for digitization of mammographic images for review and analysis; not for use as the sole basis for screening or diagnosis.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device 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

• MedScan 12 (K933632)

Submission Summary (Full Text)

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

K993598

## 510 (k) Summary As required by 807.92 For the MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers Prepared on January 17, 2000

| Submitted by: | VIDAR Systems Corporation<br>460 Spring Park Place<br>Herndon, VA 20170<br>Telephone: [phone]<br>Fax: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Drinkard<br>Medical Business Program Manager |
| Device Trade Name: | MAMMOGRAPHY PRO and Diagnostic PRO-M x-ray film digitizers. |
| Common Name: | X-ray film digitizer |
| Classification: | Medical image digitizers were reviewed by the Radiology panel and are<br>classified in Class 11 per CFR 892.2040 (proposed). |
| Predicate Device: | MedScan 12 (K933632) |
| Manufactured by: | VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170 |
| Description of Device: | The x-ray film digitizer, an electronic device used to convert analog x-ray film<br>to digital images. |
| Intended use for the device: | |

The intended use of the MAMMOGRAPHY PRO and Diagnostic PRO-M is to produce digital copies of medical x-ray films.

"The MAMMOGRAPHY PRO and Diagnostic PRO-M are indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis."

Substantial Equivalence to Predicate Device:

The MAMMOGRAPHY PRO and Diagnostic PRO-M are substantially equivalent to the MedScan 12 (K933632) film digitizer manufactured by VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170. Technical differences between the devices and the predicate raise no new issues of safety and effectiveness.

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

Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized image of an eagle's head with three lines representing the feathers. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2000

Mary "Pennie" Drinkard Medical Business Line Program Manager Vidar Systems Corporation 460 Spring Park Place Herndon, VA 20170

Re: K993598 Mammography Pro and Diagnostic PRO-M Dated: September 15, 1999 Received: October 25, 1999 Regulatory class: II 21 CFR 892.2030/90 LMA

Dear Ms. Drinkard:

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 redassified 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.

If your device is classified (see above) into either class III (Special Controls) or dass 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

CAPT Daniel G. 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

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

510(k) Number (if known): K993598

Device Name: MAMMOGRAPHY PRO and Diagnostic PRO-M

Indications for Use:

The MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers are intended for coveting analog Medical x-ray films to digital images.

The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

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

Concurrence of CDRH, Office of Devices Evaluation (ODE)

Thrid G. Sermo
(Division Si

(Division Sign-Off) (Forision Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Deproduct 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-the Counter-Use_