# K152894: Vivix-S 1717N

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Feb 26, 2016 after 149 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: 7 generations back to K803130 (1981). 25 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122866: Vivix-S with Vxvue, Vieworks Co., Ltd. (2013) Summary page 4.
- K122865: Vivix-S Wireless, Vieworks Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K181003: Vivix-S 1717V (2018), 7 descendants of its own
- K163703: Vivix-S 1417N (2017), 5 descendants of its own
- 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

## Indications for use
VIVIX-S 1717N (FXRD-1717NA, FXRD-1717NB, FXRD-1717NAW and FXRD-1717NBW) 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.

Source page: https://510kreport.com/device/K152894
Methodology: https://510kreport.com/methodology