# K221512: Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Jul 20, 2022 after 57 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: 10 generations back to K803130 (1981). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200418: Vivix-S VW, Vieworks Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K241980: !M1 (2025), 1 descendant of its own
- K251710: Mobile X-ray unit (!M1) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K221512
Methodology: https://510kreport.com/methodology