# K243142: Cranial 4Pi Immobilization

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 23, 2025 after 266 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: 3 generations back to K945903 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202050: Cranial 4Pi Immobilization, Brainlab AG (2020) Summary page 5.

## Indications for use
Cranial 4Pi is intended for patient immobilization in radiotherapy and radiosurgery procedures. Cranial 4Pi 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/K243142
Methodology: https://510kreport.com/methodology