# K954861: Brainlab CT/X-Ray Localizer

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab Med. Computersysteme GmbH
- Decided: Aug 5, 1996 after 287 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K053500: Frameless Radiosurgery Components (2006), 2 descendants of its own
- K202050: Cranial 4Pi Immobilization (2020), 1 descendant of its own
- K081935: Stereotactic Head and Neck Localizer, Model 50-100 (2008), 1 descendant of its own
- K243142: Cranial 4Pi Immobilization (2025), 0 descendants of its own
- K103616: Pinpoint Stereotactic Head and Neck Localizer (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K954861
Methodology: https://510kreport.com/methodology