# K133231: Digora Optime

- Pathway: 510(k) (Special)
- Applicant: Instrumentarium Dental, Palodex Group OY
- Decided: Mar 20, 2014 after 150 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: 2 generations back to K934949 (1994). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041050: Digora Optime (or Digora Ontime), Soredex Palodex Group OY (2004) Summary page 4.

## Most influential descendants
- K160788: RIOScan (RPS500) (2016), 6 descendants of its own
- K170733: ScanX Intraoral View (2017), 5 descendants of its own
- K212080: Imaging Plate Scanner, i-Scan (2021), 1 descendant of its own
- K202633: ScanX Edge (2020), 1 descendant of its own
- K183637: Cruxcan (CRX-1000) (2019), 1 descendant of its own

## Indications for use
The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Source page: https://510kreport.com/device/K133231
Methodology: https://510kreport.com/methodology