FDA 510(k)

MEVION S250i Proton Beam Radiation Therapy Device

Número K: K172848 · 2017-12-27

Data da decisão2017-12-27

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: LHN)

K260597VIRTUE QAProNova Solutions K260174PROBEAT-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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.