VIDAR VXR LS LASER FILM DIGITIZER

K974315 · Vidar Systems Corp. · LMA · Apr 17, 1998 · Radiology

Device Facts

• Record ID: K974315
• Device Name: VIDAR VXR LS LASER FILM DIGITIZER
• Applicant: Vidar Systems Corp.
• Product Code: LMA · Radiology
• Decision Date: Apr 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The Vidar VXR-LS Film Digitizer is intended for producing digital copies of medical x-ray films.

Device Story

VXR-LS is a laser film digitizer designed to convert radiographic film transparencies into digital images. The device operates by scanning a laser beam in one direction while a mechanical stage moves the film in an orthogonal direction. A light collector and photomultiplier capture the transmitted light, which is then processed by internal electronic circuitry for analog-to-digital conversion. The system facilitates the integration of film-based radiographs into digital networks. It is intended for use in clinical environments to support healthcare providers in viewing and managing medical images digitally, potentially improving workflow efficiency and image accessibility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laser film digitizer; incorporates laser beam scanning, mechanical stage for orthogonal film movement, light collector, and photomultiplier. Includes electronic circuitry for analog-to-digital conversion and network connectivity. Class II device per 21 CFR 892.2040.

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

• Lumiscan 75 (K934496)

Submission Summary (Full Text)

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APR 1 7 1998

## 510 (k) Summary as required by 807.92 for the VXR-LS laser film digitizer Prepared on November 7, 1997

Submitted by: VIDAR SYSTEMS CORPORATION 460 Spring Park Place Herndon, Virginia 20170 Telephone [phone] Facsimile 703 471-1165

Howard Neal Contact Person: Medical Business Line Manager.

Device Trade Name: VXR-LS.

Laser film digitizer. Common Name:

Medical image digitizers were reviewed by the Radiology Classification: Panel and are classified in Class II per 21 CFR 892.2040 (proposed).

Lumiscan 75 (K934496). Predicate Device:

Lumisys, Inc., 225 Humboldt Court, Sunnyvale, California Manufactured by: 94089.

Description of Device:

The Vidar VXR-LS is a digitizer of radiographic film transparencies incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthogonal direction, a light collector and photomultiplier and electronic circuity for analog-to-digital conversion, system operation, and connection to external networks.

Intended Use of Device:

The Vidar VXR-LS Film Digitizer is intended for producing digital copies of medical x-ray films.

Substantial Equivalence to Predicate Device:

The VXR-LS is substantially equivalent is substantially equivalent to the Lumiscan 75 (K934496) laser film digitizer manufactured by Lumisys, Inc., 225 Humboldt Court, Sunnyvale, California 94089. The principal characteristics of the two devices that are pertinent to clinical performance are compared below.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 17 1998

Bill Stamper Quality Control Manager Vidar System Corporation 460 Spring Park Place Herndon, Virginia 20170

Re:

K974315 VXR-LS Laser Film Digitizer Dated: March 18, 1998 Received: March 20, 1998 Regulatory class: Unclassified Procode: 90 LMA

Dear Mr. Stamper:

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 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 (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 (OS) for Medical Devices: General regulation (2) 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 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 predication 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 (2) 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,

William Yin

Lillian Yin, Ph Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vidar VXR-LS Film Digitizer Device Name:

Indications For Usc:

The Vidar VXR-LS Film Digitizer is intended for producing digital
ed to the first and films ine vidur medical x-ray films.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahan

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K974315

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Prescription Use
(Per 21 CFR 801.109)

-

Over-The-Counter Use

(Oplinial Formal 1-2-46)