Cleared Traditional

K252815 - ProBeam 360 Proton Therapy System v3.0 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252815 · Varian Medical Systems, Inc. · Radiology device
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Apr 2026
Decision
231d
Days
Class 2
Risk

K252815 is an FDA 510(k) clearance for the ProBeam 360 Proton Therapy System v3.0. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 23, 2026 after a review of 231 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K252815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2025
Decision Date April 23, 2026
Days to Decision 231 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 107d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LHN System, Radiation Therapy, Charged-particle, Medical

All 90
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K252815.
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K253406 · Mevion Medical Systems, Inc. · Mar 2026
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K250986 · Mevion Medical Systems, Inc. · Sep 2025
eMotus Respiratory Motion Management System
K243900 · Empnia, Inc. · Jun 2025
P-Cure Proton Therapy System (PPTS)
K242418 · P-Cure, Ltd. · May 2025
PROBEAT-FR
K232032 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Jan 2024
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
K231863 · Varian Medical Systems, Inc. · Oct 2023