FDA 510(k)

Discovery NM/CT 670 CZT

Número K: K153402 · 2016-01-21

Data da decisão2016-01-21

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Discovery NM/CT 670 CZT is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153402. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Discovery NM/CT 670 CZT?

Discovery NM/CT 670 CZT is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is GE Healthcare. The 510(k) number is K153402.

When did Discovery NM/CT 670 CZT receive FDA 510(k) clearance?

Discovery NM/CT 670 CZT received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153402.

Who is the listed applicant for Discovery NM/CT 670 CZT?

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

What is the FDA product code for Discovery NM/CT 670 CZT?

The FDA product code for Discovery NM/CT 670 CZT is KPS.

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 GE Healthcare como candidato(a)

K253639View K242925MR Contour DL K232346Digital Expert Access with Remote Scanning K223212Precision DL K221680Xeleris V Processing and Review System K221932Omni Legend

Ver todos os 55 dispositivos →

Dispositivos Relacionados (Código: KPS)

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.