FDA 510(k)

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

N.º K: K153421 · 2016-01-21

SolicitanteHitachi Aloka Medical America, Inc.

Fecha de decisión2016-01-21

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Aloka Medical America, Inc.. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153421. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Hitachi Aloka Medical America, Inc.. The 510(k) number is K153421.

When did HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS receive FDA 510(k) clearance?

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153421.

Who is the listed applicant for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

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

What is the FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

The FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is IYN.

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

Otros registros que enlistan a Hitachi Aloka Medical America, Inc. como solicitante

K152126UST-5550-R; UST-5536-R; L43K

Dispositivos relacionados (Código: IYN)

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.