FDA 510(k)

Vivid T8, Vivid T9

Número K: K181934 · 2018-11-06

RequerenteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Data da decisão2018-11-06

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vivid T8, Vivid T9 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K181934. 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 Vivid T8, Vivid T9?

Vivid T8, Vivid T9 is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K181934.

When did Vivid T8, Vivid T9 receive FDA 510(k) clearance?

Vivid T8, Vivid T9 received FDA 510(k) clearance on 2018-11-06, under 510(k) number K181934.

Who is the listed applicant for Vivid T8, Vivid T9?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivid T8, Vivid T9?

The FDA product code for Vivid T8, Vivid T9 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 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC como candidato(a)

K261668Venue Go K252718Lunar Astra K254161Automated Aortic Stenosis Software (AutoAS)K221148Vivid iq K203677ViewPoint 6 K200158LOGIQ E10

Ver todos os 15 dispositivos →

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.