FDA 510(k)

Philips IntelliSite Pathology Solution 5.1

Número K: K243871 · 2025-03-06

RequerentePhilips Medical Systems Nederland B.V.

Data da decisão2025-03-06

Código do produtoPSY

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips IntelliSite Pathology Solution 5.1 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243871. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips IntelliSite Pathology Solution 5.1?

Philips IntelliSite Pathology Solution 5.1 is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K243871.

When did Philips IntelliSite Pathology Solution 5.1 receive FDA 510(k) clearance?

Philips IntelliSite Pathology Solution 5.1 received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243871.

Who is the listed applicant for Philips IntelliSite Pathology Solution 5.1?

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

What is the FDA product code for Philips IntelliSite Pathology Solution 5.1?

The FDA product code for Philips IntelliSite Pathology Solution 5.1 is PSY.

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

Outros registros que listam Philips Medical Systems Nederland B.V. como candidato(a)

K254205Zenition 30 K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)K253614EchoNavigator R5.0 K260169AV Cardíaco CT

Ver todos os 80 dispositivos →

Dispositivos Relacionados (Código: PSY)

K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.K251952VirasightVirasoft Corporation K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics Limited K242783Roche Digital Pathology DxVentana Medical Systems, Inc.

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.