FDA 510(k)

Hura CTP v1.0

N.º K: K212550 · 2021-11-08

Fecha de decisión2021-11-08

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hura CTP v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hura Imaging, Inc.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K212550. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hura CTP v1.0?

Hura CTP v1.0 is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Hura Imaging, Inc.. The 510(k) number is K212550.

When did Hura CTP v1.0 receive FDA 510(k) clearance?

Hura CTP v1.0 received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212550.

Who is the listed applicant for Hura CTP v1.0?

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

What is the FDA product code for Hura CTP v1.0?

The FDA product code for Hura CTP v1.0 is LLZ.

Dispositivos relacionados (Código: LLZ)

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.

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.