FDA 510(k)

Vscan Air

Número K: K250087 · 2025-05-01

RequerenteGE Medical Systems Ultrasound and Primary Care Diagnostics

Data da decisão2025-05-01

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vscan Air is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250087. 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 Vscan Air?

Vscan Air is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K250087.

When did Vscan Air receive FDA 510(k) clearance?

Vscan Air received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250087.

Who is the listed applicant for Vscan Air?

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

What is the FDA product code for Vscan Air?

The FDA product code for Vscan Air 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 and Primary Care Diagnostics como candidato(a)

K261623EchoPAC Software Only / EchoPAC Plug-in (v211)K261313Vivid Explorer/Vivid Advanced/Vivid Focus K261835LOGIQ Focus K260398LOGIQ e K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power K253370LOGIQ Totus

Ver todos os 65 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.