# K232325: RAYSCAN a-Expert

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: Apr 18, 2024 after 259 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: 6 generations back to K972312 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142058: Rayscan a-Expert, Ray Co., Ltd. (2015) Summary page 5.

## Indications for use
The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.

Source page: https://510kreport.com/device/K232325
Methodology: https://510kreport.com/methodology