K231317
- 510(k) number
- K231317
- Device name
- TrueBeam, TrueBeam STx, Edge, VitalBeam
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2023-09-12
- Date received
- 2023-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231317.pdf
Official FDA record: K231317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.