Cleared Traditional

K083058 - IBA PROTON THERAPY SYSTEM - PROTEUS 235

K083058 is an FDA 510(k) clearance for IBA PROTON THERAPY SYSTEM - PROTEUS 235, manufactured by Ion Beam Applications S.A.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K083058 · Ion Beam Applications S.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
183d
Days
Class 2
Risk

K083058 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 April 15, 2009 after a review of 183 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 Ion Beam Applications S.A. devices

FDA 510(k) Submission Details - K083058

510(k) Number K083058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date April 15, 2009
Days to Decision 183 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
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHN Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K083058.
PROBEAM PROTON THERAPY SYSTEM
K133191 · Varian Medical Systems · Jan 2014
VERIFICATION CONSOLE
K124002 · Varian Medical Systems · Feb 2013
PROTON THERAPY MULTILEAF COLLIMATOR
K093250 · Varian Medical Systems · Dec 2009
ATLAS-BASED AUTOSEGMENTATION
K080799 · Computerized Medical Systems, Inc. · Aug 2008
IPLAN RT IMAGE
K080886 · Brainlab AG · Jun 2008
INTUITION IMAGE
K032511 · Brainlab AG · Jan 2004