# K972617: Helax-Visir

- Pathway: 510(k) (Traditional)
- Applicant: Helax AB
- Decided: Oct 1, 1997 after 84 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: 1 generation back to K902849 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902849: Philips Veriflex, Philips Medical Systems, Inc. (1990) Summary page 1.

## Most influential descendants
- K041719: Oncentra-Visir (2004), 0 descendants of its own

## Indications for use
Patients undergoing radiation treatment according to. prescribed treatment plan.

Source page: https://510kreport.com/device/K972617
Methodology: https://510kreport.com/methodology