K253012
- 510(k) number
- K253012
- Device name
- AlignRT Plus (8.0)
- Applicant
- Vision Rt, Ltd. GB
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-03-18
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253012.pdf
Official FDA record: K253012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.