# K122866: Vivix-S with Vxvue

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Jan 11, 2013 after 115 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: 6 generations back to K803130 (1981). 23 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120020: Vivix-S, Vieworks Co., Ltd. (2012) Summary page 3.

## Most influential descendants
- K152894: Vivix-S 1717N (2016), 9 descendants of its own
- K181003: Vivix-S 1717V (2018), 7 descendants of its own
- K163703: Vivix-S 1417N (2017), 5 descendants of its own
- K152855: Vivix-S 1012N (2016), 5 descendants of its own
- K200418: Vivix-S VW (2020), 4 descendants of its own

## Indications for use
ViVIX-S with VXvue is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography and/or for fluoroscopy.

Source page: https://510kreport.com/device/K122866
Methodology: https://510kreport.com/methodology