Cleared Traditional

K091629 - PROTEUS 235 PROTON THERAPY SYSTEM

K091629 is an FDA 510(k) clearance for PROTEUS 235 PROTON THERAPY SYSTEM, 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 69-day FDA review.

K091629 · Ion Beam Applications S.A. · Radiology device
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Aug 2009
Decision
69d
Days
Class 2
Risk

K091629 is an FDA 510(k) clearance for the PROTEUS 235 PROTON THERAPY SYSTEM. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Ion Beam Applications S.A. (Louvain-La-Neuve, Be-Nota, BE). The FDA issued a Cleared decision on August 11, 2009 after a review of 69 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.

FDA 510(k) Submission Details - K091629

510(k) Number K091629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date August 11, 2009
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHN System, Radiation Therapy, Charged-particle, Medical

All 90
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