FDA 510(k)

Exam Vue PACS

Número K: K162868 · 2017-03-17

RequerenteJpi Healthcare Solutions, Inc.

Data da decisão2017-03-17

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Exam Vue PACS is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162868. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Exam Vue PACS?

Exam Vue PACS is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Jpi Healthcare Solutions, Inc.. The 510(k) number is K162868.

When did Exam Vue PACS receive FDA 510(k) clearance?

Exam Vue PACS received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162868.

Who is the listed applicant for Exam Vue PACS?

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

What is the FDA product code for Exam Vue PACS?

The FDA product code for Exam Vue PACS is LLZ.

Dispositivos Relacionados (Código: LLZ)

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.

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, 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.