# K212753: 0909FCB, 1212FCA

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Oct 18, 2021 after 48 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: 8 generations back to K981556 (1998). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202722: 1212FCA, Rayence Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K240371: 0909FCC, 0909FCC-HS (2024), 1 descendant of its own
- K253800: 0909FCE, 0909FCE-HS (2026), 0 descendants of its own

## Indications for use
Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy 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/K212753
Methodology: https://510kreport.com/methodology