# K934949: Digora

- Pathway: 510(k) (Traditional)
- Applicant: Orion Corporation Soredex
- Decided: Feb 10, 1994 after 115 days
- Product code: IXK (System, Imaging, X-Ray, Electrostatic)
- Device class: 2
- Regulation: 21 CFR 892.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041050: Digora Optime (or Digora Ontime) (2004), 14 descendants of its own
- K133231: Digora Optime (2014), 9 descendants of its own
- K131442: Firecr Dentalimaging System (2013), 9 descendants of its own
- K160788: RIOScan (RPS500) (2016), 6 descendants of its own
- K170733: ScanX Intraoral View (2017), 5 descendants of its own

Source page: https://510kreport.com/device/K934949
Methodology: https://510kreport.com/methodology