# K092081: Qxlink

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Jul 21, 2009 after 12 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: 2 generations back to K010259 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010259: Mediface Pacs, Mediface Co., Ltd. (2001) Summary page 1.
- K083555: Picture Archiving and Communication System (Pacs), Petavision, Emsoma Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K162868: Exam Vue PACS (2017), 1 descendant of its own
- K213520: Axir-CX (2022), 0 descendants of its own

## Indications for use
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.

Source page: https://510kreport.com/device/K092081
Methodology: https://510kreport.com/methodology