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FDA 510(k)

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

K-Number: K163500 · 2017-08-17

ApplicantIon Beam Applications S.A.
Decision Date2017-08-17
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is a medical device manufactured by Ion Beam Applications S.A.. It received FDA 510(k) clearance on 2017-08-17 under approval number K163500. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)?

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by Ion Beam Applications S.A.. The 510(k) number is K163500.

When was IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) approved by the FDA?

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) received FDA 510(k) clearance on 2017-08-17, under approval number K163500.

What company makes IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)?

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is manufactured by Ion Beam Applications S.A..

What is the FDA product code for IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)?

The FDA product code for IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) is LHN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42167878 Comparative effectiveness of sulfonylureas on kidney outcomes in adults with type 2 diabetes and moderate cardiovascular risk: a target trial emulation. BMJ open diabetes research & care (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Related Devices (Code: LHN)

K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd. K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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