# K131695: Rayscan a-Expert 3D

- Pathway: 510(k) (Special)
- Applicant: Ray Co., Ltd.
- Decided: Nov 1, 2013 after 144 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: 6 generations back to K973598 (1997). 17 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122981: Rayscan a-Expert 3D, Ray Co., Ltd. (2013) Summary page 1.

## Most influential descendants
- K142247: Rayscan a-Expert 3D (2015), 22 descendants of its own
- K160525: RCT700 (2016), 11 descendants of its own
- K181452: RCT800 (2018), 10 descendants of its own
- K160140: DENTRIa    series (2016), 9 descendants of its own
- K182805: RCT800 (2018), 8 descendants of its own

## Indications for use
RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral 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 CBVT technique, to generate dlentomaxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.

Source page: https://510kreport.com/device/K131695
Methodology: https://510kreport.com/methodology