FILM SCANNER 300

K960839 · Cannon U.S.A., Inc. · LMA · Dec 18, 1996 · Radiology

Device Facts

• Record ID: K960839
• Device Name: FILM SCANNER 300
• Applicant: Cannon U.S.A., Inc.
• Product Code: LMA · Radiology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Indications for Use

Both devices are designed to digitize medical images from x-ray film.

Device Story

Desktop x-ray film digitizing system; utilizes CCD linear sensor; features automatic film feeder with 100-sheet capacity; high-speed scanning; supports DICOM and FTP protocols over TCP/IP; operated by clinical staff; converts analog film images to digital format for display and diagnostic review; facilitates digital storage and transmission of medical images.

Clinical Evidence

No clinical data; bench testing via software evaluation performed to demonstrate substantial equivalence.

Technological Characteristics

Desktop form factor; CCD linear sensor; automatic film feeder; connectivity via TCP/IP (DICOM, FTP protocols).

Indications for Use

Indicated for digitizing medical images from x-ray film 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

• Vidar VXR-12 (number not available)

Submission Summary (Full Text)

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K960839
DEC 18 1996

# 510(k) Summary (modified)

Prepared: March 29, 1996

## Submitter:

Company Name: Canon USA, Inc.
Company Address: One Canon Plaza
Lake Success, NY 11042
Contact Person: Glenn Impal, Manager
Phone Number: [phone]
Fax Number: [phone]

## Device:

Reason For 510(k): New Model
Manufacturer: Canon Inc.
Trade Name: Canon
Model Name: Film Scanner 300
Classification Name: Image Digitizer
FDA 510(k) #: K960839

## Substantial Equivalent Device:

Manufacturer: Vidar
Trade Name: Vidar
Model Name: VXR-12
Classification Name: Image Digitizer
FDA 510(k) #: NOT AVAILABLE

## Description Of Device:

The Canon Film Scanner is a desktop size x-ray film digitizing system with CCD linear sensor. Features high throughput due to high speed scan and automatic film feeder with 100 sheet capacity. DICOM and FTP protocol on TCP/IP are supported.

## Intended Use:

Both devices are designed to digitize medical images from x-ray film.

## Technical Characteristics:

Please refer to the attached COMPARISON CHART.

## Non-clinical Tests:

Software evaluation is being performed to show substantial equivalence.

## Clinical Tests:

N/A

## Conclusions:

Please wait for the completed software evaluation report to be submitted under separate cover.