Cleared Traditional

K092796 - IBA PROTON THERAPY SYSTEM, PROTEUS 235 (FDA 510(k) Clearance)

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

K092796 · Ion Beam Applications S.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
102d
Days
Class 2
Risk

K092796 is an FDA 510(k) clearance for the IBA PROTON THERAPY SYSTEM, PROTEUS 235. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Ion Beam Applications S.A. (Philadelphia, US). The FDA issued a Cleared decision on December 22, 2009 after a review of 102 days - within the typical 510(k) review window.

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 Ion Beam Applications S.A. devices

Submission Details

510(k) Number K092796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date December 22, 2009
Days to Decision 102 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
5d faster than avg
Panel avg: 107d · This submission: 102d
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 K092796.
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