# K232158: GenX-CR

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Sep 13, 2023 after 55 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: 4 generations back to K934949 (1994). 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)
- K183637: Cruxcan (CRX-1000), Cruxell Corp. (2019) Summary page 6.

## Indications for use
GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals. This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphore Storage Plate).

Source page: https://510kreport.com/device/K232158
Methodology: https://510kreport.com/methodology