# K041050: Digora Optime (or Digora Ontime)

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Jun 15, 2004 after 54 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 4 (0 Class I)
- 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.
14 later devices descend from it; 4 cite it directly.
0 of 16 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.

## Most influential descendants
- 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
- K212080: Imaging Plate Scanner, i-Scan (2021), 1 descendant of its own

## Recalls of this device
- Jan 7, 2020 · Class II · Z-0842-2020: Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The meltin
- Jan 7, 2020 · Class II · Z-0839-2020: Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The meltin
- Jan 7, 2020 · Class II · Z-0841-2020: Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The meltin
- Jan 7, 2020 · Class II · Z-0840-2020: Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The meltin

## 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/K041050
Methodology: https://510kreport.com/methodology