# K243849: 2430TCA with Xmaru W

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Mar 12, 2025 after 86 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K896095 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202902: 2430MCA with Xmaru W, Rayence Co., Ltd. (2021) Summary page 5.

## Indications for use
The 2430TCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430TCA detector.

Source page: https://510kreport.com/device/K243849
Methodology: https://510kreport.com/methodology