FDA 510(k)

Autoplaque

Número K: K212758 · 2023-05-19

RequerenteCedars-Sinai Medical Center: Aim

Data da decisão2023-05-19

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Autoplaque is the device name listed in this FDA 510(k) record. The listed applicant is Cedars-Sinai Medical Center: Aim. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K212758. 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 Autoplaque?

Autoplaque is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Cedars-Sinai Medical Center: Aim. The 510(k) number is K212758.

When did Autoplaque receive FDA 510(k) clearance?

Autoplaque received FDA 510(k) clearance on 2023-05-19, under 510(k) number K212758.

Who is the listed applicant for Autoplaque?

The FDA 510(k) record lists Cedars-Sinai Medical Center: Aim as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Autoplaque?

The FDA product code for Autoplaque is LLZ.

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: LLZ)

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.