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IBA Proton Therapy System Proteus 235

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060695

by Ion Beam Applications S.A.

Identifiers

510(k) Number
K060695 FDA 510(k)
FDA Product Code
LHN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IBA Proton Therapy System Proteus 235 is a Radiation Therapy Device, Charged-Particle designed to generate and deliver proton beams for targeted radiation treatment of localized tumors. It combines beam production equipment, including a cyclotron, with beam delivery components such as nozzles, collimators, and range verifiers, which may be mounted on fixed stations or rotatable gantries.

This system is intended for use in hospital or clinic settings by clinical staff. It operates under regulatory oversight, including an FDA 510(k) clearance (K060695) under the Special Review Advisory Committee (RA) classification, with a device classification of Class II. The system is not described as single-use or sterile in the provided data, and no MRI safety information is specified. Storage and handling instructions are not detailed in the regulatory submission.

Frequently asked questions

What clinical setting is the IBA Proton Therapy System Proteus 235 designed for, and who typically operates it?

The IBA Proton Therapy System Proteus 235 is designed for use in hospital or clinic environments. It is intended to be operated by trained clinical staff, as it combines advanced beam production (including a cyclotron) and delivery components like nozzles, collimators, and range verifiers to target localized tumors with proton radiation therapy.

How is the IBA Proton Therapy System Proteus 235 classified under FDA regulations, and what does this mean for its oversight?

The system is classified as a Class II medical device under FDA regulations and was cleared via a 510(k) submission (K060695) with a Special Review designation by the Radiology Advisory Committee. This means it undergoes additional scrutiny during the review process to ensure safety and effectiveness, though it is deemed substantially equivalent to a predicate device.

Is the IBA Proton Therapy System Proteus 235 intended for single-use or reusable applications, and what are its sterility requirements?

The provided data does not specify whether the IBA Proton Therapy System Proteus 235 is single-use or reusable. Additionally, no details about sterility requirements are mentioned, so users should refer to manufacturer guidelines for proper handling and reprocessing protocols if applicable.

What types of beam delivery components are included in the IBA Proton Therapy System Proteus 235, and how are they configured?

The system includes beam delivery components such as nozzles, collimators, and range verifiers, which can be mounted on either fixed stations or rotatable gantries. This flexibility allows for precise targeting of proton beams during radiation therapy, accommodating various treatment angles and patient positions.

Are there any specific storage or handling instructions provided for the IBA Proton Therapy System Proteus 235 in the regulatory submission?

The regulatory submission for the IBA Proton Therapy System Proteus 235 does not include detailed storage or handling instructions. Users should consult the manufacturer’s official documentation or technical manuals for proper storage, maintenance, and operational guidelines to ensure optimal performance and safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K061913) — FDA 510 (k ..., IBA Proton Therapy, Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ion Beam Applications S.A.

Sources (1)

  • FDA 510(k) K060695 24 fields · synced Sep 19, 2026