# K211317: Cruxview

- Pathway: 510(k) (Traditional)
- Applicant: Cruxell Corp.
- Decided: Jul 29, 2021 after 90 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 K896095 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983267: Digora for Windows 2.0, Orion Corporation Soredex (1998) Summary page 4.

## Indications for use
The CRUXVIEW is a software intended for using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses.

Source page: https://510kreport.com/device/K211317
Methodology: https://510kreport.com/methodology