# K260820: Vivix-S 4386W (FXRD-4386WA)

- Pathway: 510(k) (Special)
- Applicant: Vieworks Co., Ltd.
- Decided: Jun 18, 2026 after 97 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: 10 generations back to K803130 (1981). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220239: Solid State X-ray Imager (Model: FXRD-4386WB), Vieworks Co., Ltd. (2022) Summary page 5.

## 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/K260820
Methodology: https://510kreport.com/methodology