FDA 510(k)

RSI-MRI+

Número K: K191278 · 2019-11-19

RequerenteMultimodal Imaging Services Corporation (Dba Healthlytix)

Data da decisão2019-11-19

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

RSI-MRI+ is the device name listed in this FDA 510(k) record. The listed applicant is Multimodal Imaging Services Corporation (Dba Healthlytix). It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K191278. 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 RSI-MRI+?

RSI-MRI+ is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Multimodal Imaging Services Corporation (Dba Healthlytix). The 510(k) number is K191278.

When did RSI-MRI+ receive FDA 510(k) clearance?

RSI-MRI+ received FDA 510(k) clearance on 2019-11-19, under 510(k) number K191278.

Who is the listed applicant for RSI-MRI+?

The FDA 510(k) record lists Multimodal Imaging Services Corporation (Dba Healthlytix) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RSI-MRI+?

The FDA product code for RSI-MRI+ 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.