K240431
- 510(k) number
- K240431
- Device name
- ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
- Applicant
- Brainlab AG DE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2024-07-24
- Date received
- 2024-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240431.pdf
Official FDA record: K240431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.