# K934657: Brainlab Linac Hardware

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab Med. Computersysteme GmbH
- Decided: Jul 22, 1994 after 304 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K073018: Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight (2008), 2 descendants of its own
- K081935: Stereotactic Head and Neck Localizer, Model 50-100 (2008), 1 descendant of its own
- K103616: Pinpoint Stereotactic Head and Neck Localizer (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K934657
Methodology: https://510kreport.com/methodology