K243142
- 510(k) number
- K243142
- Device name
- Cranial 4Pi Immobilization
- Applicant
- Brainlab AG DE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2025-06-23
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243142.pdf
Official FDA record: K243142
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.