Cleared Traditional

TrueBeam, TrueBeam STx, Edge, VitalBeam

K231317 · Varian Medical Systems, Inc. · Radiology
Sep 2023
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K231317 is an FDA 510(k) clearance for the TrueBeam, TrueBeam STx, Edge, 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 September 12, 2023, 127 days after receiving the submission on May 8, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K231317 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2023
Decision Date September 12, 2023
Days to Decision 127 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

Similar Devices — IYE Accelerator, Linear, Medical

All 727
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
K252188 · Elekta Solutions AB · Jan 2026
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
K254010 · Brainlab SE · Jan 2026
ChartCheck (RADCH V1.6)
K252988 · Radformation, Inc. · Jan 2026
IDENTIFY (5.0)
K252919 · Varian Medical Systems, Inc. · Dec 2025
ZAP-X Radiosurgery System (ZAP-X)
K250392 · Zap Surgical Systems, Inc. · Nov 2025