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FDA 510(k)

MEVION S250i Proton Beam Radiation Therapy Device

N.º K: K172848 · 2017-12-27

SolicitanteMevion Medical Systems
Fecha de decisión2017-12-27
Código de productoLHN
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

MEVION S250i Proton Beam Radiation Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Mevion Medical Systems. It received FDA 510(k) clearance on 2017-12-27 under 510(k) number K172848. 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 MEVION S250i Proton Beam Radiation Therapy Device?

MEVION S250i Proton Beam Radiation Therapy Device is a medical device that received FDA 510(k) clearance on 2017-12-27. The listed applicant is Mevion Medical Systems. The 510(k) number is K172848.

When did MEVION S250i Proton Beam Radiation Therapy Device receive FDA 510(k) clearance?

MEVION S250i Proton Beam Radiation Therapy Device received FDA 510(k) clearance on 2017-12-27, under 510(k) number K172848.

Who is the listed applicant for MEVION S250i Proton Beam Radiation Therapy Device?

The FDA 510(k) record lists Mevion Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEVION S250i Proton Beam Radiation Therapy Device?

The FDA product code for MEVION S250i Proton Beam Radiation Therapy Device 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

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