# K181003: Vivix-S 1717V

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: May 15, 2018 after 29 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.
7 later devices descend from it; 2 cite it directly.
0 of 34 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
- K220239: Solid State X-ray Imager (Model: FXRD-4386WB) (2022), 1 descendant of its own
- K260820: Vivix-S 4386W (FXRD-4386WA) (2026), 0 descendants of its own

## Indications for use
VIVIX-S 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.

Source page: https://510kreport.com/device/K181003
Methodology: https://510kreport.com/methodology