# K251410: VXvue

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Nov 4, 2025 after 181 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K896095 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231225: EConsole1, DRTECH Corporation (2023) Summary page 5.

## Indications for use
VXvue is intended to acquire Digital images from X-ray Detectors, process the images to facilitate diagnosis and to display, and transfer the resulting images to other devices for diagnostic purpose. VXvue is indicated for use in general radiographic images of human anatomy. And it is not for fluoroscopic, angiographic, and mammographic applications.

Source page: https://510kreport.com/device/K251410
Methodology: https://510kreport.com/methodology