# K070304: Digora PCT/Digipod

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Mar 27, 2007 after 55 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 K951373 (1995). 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)
- K951373: Fuji Computed Radiography System FCR9000HQ, FCR9501HQ, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 2.

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

Source page: https://510kreport.com/device/K070304
Methodology: https://510kreport.com/methodology