Cleared Traditional

K133191 - PROBEAM PROTON THERAPY SYSTEM (FDA 510(k) Clearance)

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

K133191 · Varian Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
85d
Days
Class 2
Risk

K133191 is an FDA 510(k) clearance for the PROBEAM PROTON THERAPY SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Varian Medical Systems devices

Submission Details

510(k) Number K133191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date January 10, 2014
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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 K133191.
ProBeam 360 Proton Therapy System v3.0
K252815 · Varian Medical Systems, Inc. · Apr 2026
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