K243301
- 510(k) number
- K243301
- Device name
- MapRT
- Applicant
- Vision Rt, Ltd. GB
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2025-05-19
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243301.pdf
Official FDA record: K243301
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.