FDA 510(k)

Simpleware ScanIP Medical

Número K: K203195 · 2021-04-01

RequerenteSynopsys (Northern Europe) , Ltd.

Data da decisão2021-04-01

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Simpleware ScanIP Medical is the device name listed in this FDA 510(k) record. The listed applicant is Synopsys (Northern Europe) , Ltd.. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K203195. 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 Simpleware ScanIP Medical?

Simpleware ScanIP Medical is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Synopsys (Northern Europe) , Ltd.. The 510(k) number is K203195.

When did Simpleware ScanIP Medical receive FDA 510(k) clearance?

Simpleware ScanIP Medical received FDA 510(k) clearance on 2021-04-01, under 510(k) number K203195.

Who is the listed applicant for Simpleware ScanIP Medical?

The FDA 510(k) record lists Synopsys (Northern Europe) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simpleware ScanIP Medical?

The FDA product code for Simpleware ScanIP Medical 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.