# K120020: Vivix-S

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: May 4, 2012 after 122 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: 5 generations back to K803130 (1981). 22 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024147: Paxscan 4030 Medical Digital Imaging System, Varian Medical Systems, Inc. (2003) Summary page 2.
- K090742: Digital Flat Panel X-Ray Detector, Model LTX240AA01-a, Samsung Mobile Display Co., Ltd. (2009) Summary page 2.

## Most influential descendants
- K122865: Vivix-S Wireless (2013), 28 descendants of its own
- K150929: CareView 1500Cw X-ray Flat Panel Detectors (2015), 12 descendants of its own
- K122866: Vivix-S with Vxvue (2013), 11 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

## Indications for use
ViVIX-S 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/K120020
Methodology: https://510kreport.com/methodology