# K012170: Digora PCT

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Aug 10, 2001 after 29 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934949 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934949: Digora, Orion Corporation Soredex (1994) Summary page 1.
- (no number) Conventional film screen combination (Kodak T-Mat G film/Lanex Regular intensifying screens): named in the summary without a submission number

## Indications for use
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial and cephalometric x-ray images stored in imaging plate recording media.

Source page: https://510kreport.com/device/K012170
Methodology: https://510kreport.com/methodology