# K241125: Vivix-S 1751S

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Nov 15, 2024 after 206 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: 1 generation back to K190611 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190611: Vivix-S 1751S, Vieworks Co., Ltd. (2019) Summary page 5.

## Indications for use
VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.

Source page: https://510kreport.com/device/K241125
Methodology: https://510kreport.com/methodology