Iba Proton Therapy System, Model Proteus 235
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100766 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, Model Proteus 235, is a radiation therapy system that generates and delivers proton beams for the treatment of localized tumors. It is an external beam irradiation system that delivers therapeutic proton beams to a patient's treatment site. The system consists of beam production equipment, a beam delivery system, a therapy safety system, and a computer-based therapy control system.
The system is supplied with components including a cyclotron for beam production, beam delivery equipment such as nozzles, collimators, and range verifiers, and a patient positioning system. It is designed to treat patients with malignant tumors in various parts of the body, utilizing the physical properties of protons to deposit their maximum energy. The system has been authorized with an FDA 510K clearance.
Frequently asked questions
What is the Iba Proton Therapy System used for?
The system is designed to treat patients with malignant tumors in various parts of the body, utilizing the physical properties of protons to deposit their maximum energy.
What components are included with the system?
The system is supplied with components including a cyclotron for beam production, beam delivery equipment such as nozzles, collimators, and range verifiers, and a patient positioning system.
Is the system authorized for use?
Yes, the system has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
What type of radiation therapy does the system deliver?
The system delivers external beam irradiation, specifically proton beams, to a patient's treatment site.
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 - Innolitics, IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K083058) — FDA 510 (k ..., "IBA" Proteus 235 Proton Therapy System and accessories Proteus®PLUS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100766 | Class II | Active |
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Manufacturer
- Manufacturer
- Ion Beam Applications S.A.
Sources (1)
- FDA 510(k) K100766 24 fields · synced Sep 24, 2026