# K202050: Cranial 4Pi Immobilization

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Aug 19, 2020 after 26 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: 2 generations back to K945903 (1995). 3 ancestors in all.
1 later device descends 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)
- K053500: Frameless Radiosurgery Components, Brainlab AG (2006) Summary page 4.

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

## Indications for use
The Cranial 4Pi Immobilization is a device used for immobilization of the patient’s •cranial area •head and neck area in a CT- and linear accelerator environment. The Cranial 4Pi Immobilization device is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.

Source page: https://510kreport.com/device/K202050
Methodology: https://510kreport.com/methodology