FDA 510(k)

DeepFoqus (DeepFoqus-Accelerate)

Número K: K241982 · 2025-04-04

Data da decisão2025-04-04

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

DeepFoqus (DeepFoqus-Accelerate) is the device name listed in this FDA 510(k) record. The listed applicant is Foqus Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K241982. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DeepFoqus (DeepFoqus-Accelerate)?

DeepFoqus (DeepFoqus-Accelerate) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Foqus Technologies, Inc.. The 510(k) number is K241982.

When did DeepFoqus (DeepFoqus-Accelerate) receive FDA 510(k) clearance?

DeepFoqus (DeepFoqus-Accelerate) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K241982.

Who is the listed applicant for DeepFoqus (DeepFoqus-Accelerate)?

The FDA 510(k) record lists Foqus Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepFoqus (DeepFoqus-Accelerate)?

The FDA product code for DeepFoqus (DeepFoqus-Accelerate) is QIH.

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

Dispositivos Relacionados (Código: QIH)

K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K262390BoneXpertVisiana K261368Rapid Platform (R6.7)Ischemaview, Inc.K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

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.