FDA 510(k)

Radialis PET Camera

N.º K: K214062 · 2022-02-04

Fecha de decisión2022-02-04

Código de productoKPS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Radialis PET Camera is the device name listed in this FDA 510(k) record. The listed applicant is Radialis, Inc.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K214062. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Radialis PET Camera?

Radialis PET Camera is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Radialis, Inc.. The 510(k) number is K214062.

When did Radialis PET Camera receive FDA 510(k) clearance?

Radialis PET Camera received FDA 510(k) clearance on 2022-02-04, under 510(k) number K214062.

Who is the listed applicant for Radialis PET Camera?

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

What is the FDA product code for Radialis PET Camera?

The FDA product code for Radialis PET Camera is KPS.

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: KPS)

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.