Cleared Traditional

TrueBeam, TrueBeam STX, Edge and VitalBeam

K252948 · Varian Medical Systems, Inc. · Radiology
Oct 2025
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K252948 is an FDA 510(k) clearance for the TrueBeam, TrueBeam STX, Edge and VitalBeam, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 7, 2025, 21 days after receiving the submission on September 16, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252948 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2025
Decision Date October 07, 2025
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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