FDA 510(k)

Automated Aortic Stenosis Software (AutoAS)

Número K: K254161 · 2026-03-27

RequerenteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Data da decisão2026-03-27

Código do produtoPOK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Automated Aortic Stenosis Software (AutoAS) 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 2026-03-27 under 510(k) number K254161. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Automated Aortic Stenosis Software (AutoAS)?

Automated Aortic Stenosis Software (AutoAS) is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K254161.

When did Automated Aortic Stenosis Software (AutoAS) receive FDA 510(k) clearance?

Automated Aortic Stenosis Software (AutoAS) received FDA 510(k) clearance on 2026-03-27, under 510(k) number K254161.

Who is the listed applicant for Automated Aortic Stenosis Software (AutoAS)?

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 Automated Aortic Stenosis Software (AutoAS)?

The FDA product code for Automated Aortic Stenosis Software (AutoAS) is POK.

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 K221148Vivid iq K203677ViewPoint 6 K200158LOGIQ E10 K191112GEHC DXA Bone Densitometers with enCORE version 18

Ver todos os 15 dispositivos →

Dispositivos Relacionados (Código: POK)

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonio K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx K252294Fetal EchoScan (v1.2)Brightheart K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.K251071Fetal EchoScan (v1.1)Brightheart

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.