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Diagnosticpro Edge

by Vidar Systems Corp.

510(k) K130406

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130406 Date29 Apr 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LMA
Device class
Class II
Regulation
21 CFR Part 892.2030
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DiagnosticPRO Edge Film Digitizer is a radiological image digitizer designed to convert analog radiographic films into digital images. Classified as a radiological digitizer under the nomenclature authority, it facilitates the transition from film-based to digital radiology workflows by capturing high-resolution scans of X-ray films for further analysis and storage.

This device is intended for use in radiology settings and is supplied as a reusable, non-sterile medical instrument. It operates with compatible Windows operating systems (32-bit and 64-bit) and requires specific power adapters for certain serial number ranges (e.g., serial numbers 380,000–389,999 use Vidar part number 40). The device holds an FDA 510(k) clearance under the Radiology Advisory Committee, classified as a Class II medical device (K130406).

Similar devices

Other devices filed under FDA product code LMA (Digitizer, Image, Radiological).

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