# K220239: Solid State X-ray Imager (Model: FXRD-4386WB)

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Sep 13, 2022 after 228 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). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 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.

## Most influential descendants
- K260820: Vivix-S 4386W (FXRD-4386WA) (2026), 0 descendants of its own

## Indications for use
VIVIX-S 4386W is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography. It is intended for both adult and pediatric populations.

Source page: https://510kreport.com/device/K220239
Methodology: https://510kreport.com/methodology