# K130406: Diagnosticpro Edge

- Pathway: 510(k) (Traditional)
- Applicant: Vidar Systems Corp.
- Decided: Apr 29, 2013 after 69 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933632 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993598: Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205, Vidar Systems Corp. (2000) Summary page 1.

## Indications for use
The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation. The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

Source page: https://510kreport.com/device/K130406
Methodology: https://510kreport.com/methodology