Cleared Traditional

ProBeam 360? Proton Therapy System v2.0 (Multiroom)

K231863 · Varian Medical Systems, Inc. · Radiology
Oct 2023
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K231863 is an FDA 510(k) clearance for the ProBeam 360? Proton Therapy System v2.0 (Multiroom), a System, Radiation Therapy, Charged-particle, Medical (Class II — Special Controls, product code LHN), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 6, 2023, 105 days after receiving the submission on June 23, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K231863 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2023
Decision Date October 06, 2023
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LHN — System, Radiation Therapy, Charged-particle, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

Similar Devices — LHN System, Radiation Therapy, Charged-particle, Medical

All 88
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
P-Cure Proton Beam Therapy System
K221996 · P-Cure, Ltd. · Mar 2023
Small Field Applicator
K220883 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Dec 2022