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FDA 510(k)

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

N.º K: K213438 · 2022-01-19

SolicitanteAdaptiiv
Fecha de decisión2022-01-19
Código de productoMUJ
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Adaptiiv. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K213438. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory?

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Adaptiiv. The 510(k) number is K213438.

When did 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory receive FDA 510(k) clearance?

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory received FDA 510(k) clearance on 2022-01-19, under 510(k) number K213438.

Who is the listed applicant for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory?

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

What is the FDA product code for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory?

The FDA product code for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory is MUJ.

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Dispositivos relacionados (Código: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, 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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