# K202902: 2430MCA with Xmaru W

- Pathway: 510(k) (Traditional)
- Applicant: Rayence Co., Ltd.
- Decided: Jun 21, 2021 after 265 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: 10 generations back to K896095 (1990). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162670: RSM 1824C with RConsole1, DRTECH Corporation (2017) Summary page 4.

## Most influential descendants
- K243849: 2430TCA with Xmaru W (2025), 0 descendants of its own

## Indications for use
The 2430MCA 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 2430MCA detector.

Source page: https://510kreport.com/device/K202902
Methodology: https://510kreport.com/methodology