# K253800: 0909FCE, 0909FCE-HS

- Pathway: 510(k) (Traditional)
- Applicant: Rayence Co., Ltd.
- Decided: Jul 31, 2026 after 245 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K981556 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240371: 0909FCC, 0909FCC-HS, Rayence Co., Ltd. (2024) Summary page 5.

## Indications for use
0909FCE and 0909FCE-HS are indicated for digital imaging solution designed including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

Source page: https://510kreport.com/device/K253800
Methodology: https://510kreport.com/methodology