# K163703: Vivix-S 1417N

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Feb 8, 2017 after 41 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: 8 generations back to K803130 (1981). 26 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152894: Vivix-S 1717N, Vieworks Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K200418: Vivix-S VW (2020), 4 descendants of its own
- K221512: Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) (2022), 2 descendants of its own
- K241980: !M1 (2025), 1 descendant of its own
- K251710: Mobile X-ray unit (!M1) (2025), 0 descendants of its own
- K211790: DX-D Imaging Package with XD Detectors (2021), 0 descendants of its own

## Indications for use
VIVIX-S 1417N Series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems. The VIVIX-S 1417N Series is not intended for mammography applications.

Source page: https://510kreport.com/device/K163703
Methodology: https://510kreport.com/methodology