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FDA 510(k)

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

N.º K: K152224 · 2016-08-09

SolicitanteIon Beam Application S.A.
Fecha de decisión2016-08-09
Código de productoLHN
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) is the device name listed in this FDA 510(k) record. The listed applicant is Ion Beam Application S.A.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K152224. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Ion Beam Application S.A.. The 510(k) number is K152224.

When did Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) receive FDA 510(k) clearance?

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

Who is the listed applicant for Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)?

The FDA 510(k) record lists Ion Beam Application S.A. as the applicant. This does not by itself establish the device manufacturer.

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.

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Dispositivos relacionados (Código: LHN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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