FDA 510(k)

ALOKA ARIETTA 850

Número K: K171708 · 2017-10-31

RequerenteHitachi Healthcare Americas Corporation

Data da decisão2017-10-31

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ALOKA ARIETTA 850 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K171708. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ALOKA ARIETTA 850?

ALOKA ARIETTA 850 is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K171708.

When did ALOKA ARIETTA 850 receive FDA 510(k) clearance?

ALOKA ARIETTA 850 received FDA 510(k) clearance on 2017-10-31, under 510(k) number K171708.

Who is the listed applicant for ALOKA ARIETTA 850?

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

What is the FDA product code for ALOKA ARIETTA 850?

The FDA product code for ALOKA ARIETTA 850 is IYN.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Hitachi Healthcare Americas Corporation como candidato(a)

K181376ARIETTA 65 K173739ALOKA ARIETTA 850 K172110ECHELON OVAL V6.0A MRI System K171738Supria True64

Dispositivos Relacionados (Código: IYN)

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.