FDA 510(k)

Radiance 330 Proton Beam Therapy System

N.º K: K191521 · 2019-09-27

SolicitanteProtom International Holding Corporation

Fecha de decisión2019-09-27

Código de productoLHN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Radiance 330 Proton Beam Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Protom International Holding Corporation. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K191521. 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 Radiance 330 Proton Beam Therapy System?

Radiance 330 Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Protom International Holding Corporation. The 510(k) number is K191521.

When did Radiance 330 Proton Beam Therapy System receive FDA 510(k) clearance?

Radiance 330 Proton Beam Therapy System received FDA 510(k) clearance on 2019-09-27, under 510(k) number K191521.

Who is the listed applicant for Radiance 330 Proton Beam Therapy System?

The FDA 510(k) record lists Protom International Holding Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiance 330 Proton Beam Therapy System?

The FDA product code for Radiance 330 Proton Beam Therapy System is LHN.

Ensayos clínicos relacionados

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.

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.

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.