FDA 510(k)

XR90 (XR90-SYS)

Número K: K223125 · 2023-07-13

Data da decisão2023-07-13

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

XR90 (XR90-SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Mediview Xr, Inc.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K223125. 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 XR90 (XR90-SYS)?

XR90 (XR90-SYS) is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Mediview Xr, Inc.. The 510(k) number is K223125.

When did XR90 (XR90-SYS) receive FDA 510(k) clearance?

XR90 (XR90-SYS) received FDA 510(k) clearance on 2023-07-13, under 510(k) number K223125.

Who is the listed applicant for XR90 (XR90-SYS)?

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

What is the FDA product code for XR90 (XR90-SYS)?

The FDA product code for XR90 (XR90-SYS) 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.