# K053500: Frameless Radiosurgery Components

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Feb 3, 2006 after 49 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 K945903 (1995). 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)
- K945903: Brainlab Mask System, Brainlab Med. Computersysteme GmbH (1995) Summary page 1.
- K954861: Brainlab CT/X-Ray Localizer, Brainlab Med. Computersysteme GmbH (1996) Summary page 1.

## Most influential descendants
- K202050: Cranial 4Pi Immobilization (2020), 1 descendant of its own
- K243142: Cranial 4Pi Immobilization (2025), 0 descendants of its own

## Indications for use
The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's - head and neck - head, neck, and shoulders in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

Source page: https://510kreport.com/device/K053500
Methodology: https://510kreport.com/methodology