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FDA 510(k)

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

K-Number: K152224 · 2016-08-09

ApplicantIon Beam Application S.A.
Decision Date2016-08-09
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is a medical device manufactured by Ion Beam Application S.A.. It received FDA 510(k) clearance on 2016-08-09 under approval number K152224. 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 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)?

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is a medical device that received FDA 510(k) clearance on 2016-08-09. It is manufactured by Ion Beam Application S.A.. The 510(k) number is K152224.

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

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) received FDA 510(k) clearance on 2016-08-09, under approval number K152224.

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

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

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

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

Related Clinical Trials

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Related PubMed Literature

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Related Devices (Code: LHN)

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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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