FDA 510(k)

EchoPAC Software Only / EchoPAC Plug-in (v211)

Número K: K261623 · 2026-09-16

RequerenteGE Medical Systems Ultrasound and Primary Care Diagnostics

Data da decisão2026-09-16

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EchoPAC Software Only / EchoPAC Plug-in (v211) 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 2026-09-16 under 510(k) number K261623. 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 EchoPAC Software Only / EchoPAC Plug-in (v211)?

EchoPAC Software Only / EchoPAC Plug-in (v211) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K261623.

When did EchoPAC Software Only / EchoPAC Plug-in (v211) receive FDA 510(k) clearance?

EchoPAC Software Only / EchoPAC Plug-in (v211) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261623.

Who is the listed applicant for EchoPAC Software Only / EchoPAC Plug-in (v211)?

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 EchoPAC Software Only / EchoPAC Plug-in (v211)?

The FDA product code for EchoPAC Software Only / EchoPAC Plug-in (v211) 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

Outros registros que listam GE Medical Systems Ultrasound and Primary Care Diagnostics como candidato(a)

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 K253366LOGIQ Fortis

Ver todos os 65 dispositivos →

Dispositivos Relacionados (Código: QIH)

K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K262390BoneXpertVisiana K261368Rapid Platform (R6.7)Ischemaview, Inc.K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.

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.