# K130636: Teleradpro Edge; Teleradpro Edge HD-CCD

- Pathway: 510(k) (Traditional)
- Applicant: Vidar Systems Corp.
- Decided: Jun 7, 2013 after 88 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: 3 generations back to K933632 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102476: Teleradpro, Vidar Systems Corp. (2010) Summary page 1.

## Indications for use
The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are 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. These devices are not intended to be used for primary diagnosis in mammography applications.

Source page: https://510kreport.com/device/K130636
Methodology: https://510kreport.com/methodology