# K122865: Vivix-S Wireless

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Feb 1, 2013 after 136 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.
28 later devices descend from it; 5 cite it directly.
0 of 52 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 1.

## Most influential descendants
- K150929: CareView 1500Cw X-ray Flat Panel Detectors (2015), 12 descendants of its own
- K152894: Vivix-S 1717N (2016), 9 descendants of its own
- K153058: CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors (2015), 8 descendants of its own
- K181003: Vivix-S 1717V (2018), 7 descendants of its own
- K163703: Vivix-S 1417N (2017), 5 descendants of its own

## Indications for use
ViVIX-S wireless 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/K122865
Methodology: https://510kreport.com/methodology