K254010
- 510(k) number
- K254010
- Device name
- ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
- Applicant
- Brainlab SE DE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-01-14
- Date received
- 2025-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K254010.pdf
Official FDA record: K254010
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.