# K200418: Vivix-S VW

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Mar 18, 2020 after 27 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: 9 generations back to K803130 (1981). 29 ancestors in all.
4 later devices descend from it; 3 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)
- K181003: Vivix-S 1717V, Vieworks Co., Ltd. (2018) Summary page 4.
- K163703: Vivix-S 1417N, Vieworks Co., Ltd. (2017) Summary page 5.
- K152855: Vivix-S 1012N, Vieworks Co., Ltd. (2016). Our reading of the summary gave K152885, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VIVIX-S 1012N”. Summary page 8.

## Most influential descendants
- 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 VW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S VW series is not intended for mammography applications.

Source page: https://510kreport.com/device/K200418
Methodology: https://510kreport.com/methodology