PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617

K993597 · Vidar Systems Corp. · LMA · Dec 15, 1999 · Radiology

Device Facts

• Record ID: K993597
• Device Name: PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
• Applicant: Vidar Systems Corp.
• Product Code: LMA · Radiology
• Decision Date: Dec 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The intended use of the P111, TeleRADPRO, and VXR-12 plus is to produce digital copies of medical x-ray films. The VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers are intended for producing digital copies of medical x-ray films.

Device Story

Device is an electronic x-ray film digitizer; converts analog x-ray films into digital images. Used in clinical settings to facilitate digital storage, transmission, or review of radiographic studies. Operates by scanning physical film media to produce electronic output. Healthcare providers use digital output for diagnostic review and clinical decision-making. Benefits include transition from analog to digital imaging workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic x-ray film digitizer; converts analog film to digital format. Class II device per 21 CFR 892.2030.

Indications for Use

Indicated for the production of digital copies of medical x-ray films for clinical use.

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)

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K99 3597

DEC 1 5 1999

## 510 (k) Summary As required by 807.92 For the P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers Prepared on August 3, 1999

| Submitted by: | VIDAR Systems Corporation<br>460 Spring Park Place<br>Herndon, VA 20170<br>Telephone: [phone]<br>Fax: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary "Pennie" Drinkard<br>Medical Business Line Program Manager |
| Device Trade Name: | P111, TeleRADPRO, and VXR-12 plus 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 is an electronic device used to convert analog x-ray<br>films to digital images. |
| Intended use for the device: | |

The intended use of the P111, TeleRADPRO, and VXR-12 plus is to produce digital copies of medical x-ray films.

The VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers are intended for producing digital copies of medical x-ray films.

Substantial Equivalence to Predicate Device:

The P111, TeleRADPRO, and VXR-12 plus 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 of safety and effectiveness.

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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 features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | 5 |999

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

Re:

K993597 Vidar Sierra, TeleRADPRO and VXR-12 plus Film Digitizers Dated: July 29, 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 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.

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 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 requlatory 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.

ff 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/dsma/dsmamain.html".

Sincerely yours,

BART D. JACOBS, M.D.

APT 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

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K99 3597 510 k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: P 111, TeleRADPRO, and VXR-12 plus.

Indications for use:

The VIDAR P 111, TeleRADPRO, and VXR-12 plus film digitizers are intended for making digital copies of medical x-ray films.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Neyman

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-counter Use __