# K172534: LINACwatch, LinacView

- Pathway: 510(k) (Traditional)
- Applicant: Qualiformed Sarl
- Decided: Oct 27, 2017 after 66 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914698 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140660: MOBIUS3D, Mobius Medical Systems, LP (2014) Summary page 5.
- K141800: Perfraction, Sun Nuclear Corporation (2014) Summary page 5.

## Indications for use
QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow. QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.

Source page: https://510kreport.com/device/K172534
Methodology: https://510kreport.com/methodology