# K183637: Cruxcan (CRX-1000)

- Pathway: 510(k) (Traditional)
- Applicant: Cruxell Corp.
- Decided: Feb 12, 2019 after 48 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: 3 generations back to K934949 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K133231: Digora Optime, Instrumentarium Dental, Palodex Group OY (2014) Summary page 5.

## Most influential descendants
- K232158: GenX-CR (2023), 0 descendants of its own

## Indications for use
The CRUXCAN (CRX-1000) 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/K183637
Methodology: https://510kreport.com/methodology