Cleared Special

K101508 - MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235

K101508 is an FDA 510(k) clearance for MODIFICATION TO IBA PROTON THERAPY SYST..., manufactured by Ion Beam Applications S.A.. The device is a Class 2 Radiology device with product code LHN cleared through the Special 510(k) pathway after a 66-day FDA review.

K101508 · Ion Beam Applications S.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
66d
Days
Class 2
Risk

K101508 is an FDA 510(k) clearance for the MODIFICATION TO 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 August 6, 2010 after a review of 66 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K101508

510(k) Number K101508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2010
Decision Date August 06, 2010
Days to Decision 66 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 92
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K101508.
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
K112768 · Calypso Medical Technologies, Inc. · Nov 2011
PT2 VARIAN PROTON THERAPY SYSTEM
K101294 · Varian Medical Systems, Oncology Systems · Dec 2010
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
K102373 · Calypso Medical Technologies, Inc. · Sep 2010
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
K100766 · Ion Beam Applications S.A. · Jul 2010
PROTON THERAPY MULTILEAF COLLIMATOR
K093250 · Varian Medical Systems · Dec 2009
IBA PROTON THERAPY SYSTEM, PROTEUS 235
K092796 · Ion Beam Applications S.A. · Dec 2009
K101508 · MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
Download PDF FDA Summary Ion Beam Applications…