# K232287: RAYSCAN a-Expert3D

- Pathway: 510(k) (Special)
- Applicant: Ray Co., Ltd.
- Decided: Aug 31, 2023 after 30 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K190812 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190812: RAYSCAN a-Expert3D, Ray Co., Ltd. (2019) Summary page 6.

## Indications for use
RAYSCAN oa-Expert3D, panoramic x-ray imaging system with cephalostat, is an extra-oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images. The device uses cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.

Source page: https://510kreport.com/device/K232287
Methodology: https://510kreport.com/methodology