Cleared Traditional

K163500 - IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)

K163500 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 247-day FDA review.

K163500 · Ion Beam Applications S.A. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2017
Decision
247d
Days
Class 2
Risk

K163500 is an FDA 510(k) clearance for the IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK.... 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). The FDA issued a Cleared decision on August 17, 2017 after a review of 247 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 - K163500

510(k) Number K163500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2016
Decision Date August 17, 2017
Days to Decision 247 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 107d · This submission: 247d
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 Consultant

Saul Ewing Llp
Bruce D Armon

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 76
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