FDA 510(k)

Image Management V15

Número K: K240822 · 2024-04-24

RequerentePhilips Medical Systems Technologies

Data da decisão2024-04-24

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Image Management V15 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Technologies. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K240822. 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 Image Management V15?

Image Management V15 is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Philips Medical Systems Technologies. The 510(k) number is K240822.

When did Image Management V15 receive FDA 510(k) clearance?

Image Management V15 received FDA 510(k) clearance on 2024-04-24, under 510(k) number K240822.

Who is the listed applicant for Image Management V15?

The FDA 510(k) record lists Philips Medical Systems Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Management V15?

The FDA product code for Image Management V15 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.