# K241113: Vivix-M

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Jan 16, 2025 after 269 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)
- K170930: RSM 2430C, DRTECH Corporation (2017) Summary page 5.

## Indications for use
VIVIX-M detectors are flat panel detectors used in mammographic applications to acquire digital images for screening and diagnosis.

Source page: https://510kreport.com/device/K241113
Methodology: https://510kreport.com/methodology