K252948

TrueBeam, TrueBeam STX, Edge and VitalBeam

510(k) number
K252948
Device name
TrueBeam, TrueBeam STX, Edge and VitalBeam
Applicant
Varian Medical Systems, Inc. CA · US
Product code
IYE — Accelerator, Linear, Medical
Decision date
2025-10-07
Date received
2025-09-16
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K252948.pdf

Official FDA record: K252948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.