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Philips Medical Systems Nederland B.V.

FDA 510(k) & PMA Approved Devices — 80 products

Total Devices80
Categories12
Latest FDA decision2026-08-07
TypeNumberDevice NameCodeDateActions
510(k) K254205 Zenition 30OWB2026-08-07 View
510(k) K262330 dS 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 3.0TMOS2026-07-30 View
510(k) K262294 dS 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 3.0TMOS2026-07-24 View
510(k) K260207 Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ2026-05-27 View
510(k) K253614 EchoNavigator R5.0QIH2026-03-17 View
510(k) K260169 AV Cardiac CTJAK2026-03-05 View
510(k) K253648 Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including UpgradesLNH2026-02-23 View
510(k) K253735 AV VascularQIH2026-01-22 View
510(k) K254190 dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS2026-01-14 View
510(k) K252645 LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK2025-10-24 View
510(k) K251215 Philips IntelliSpace CardiovascularLLZ2025-10-02 View
510(k) K250181 AV ViewerLLZ2025-07-15 View
510(k) K251808 Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR SystemsLNH2025-07-11 View
510(k) K250648 Philips iCT CT systemJAK2025-06-27 View
510(k) K251397 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemLNH2025-06-04 View
510(k) K242001 Philips VSC-MEDlibBZQ2025-04-04 View
510(k) K243871 Philips IntelliSite Pathology Solution 5.1PSY2025-03-06 View
510(k) K242848 Philips IntelliSite Pathology Solution 5.1PSY2024-12-10 View
510(k) K241871 Philips IntelliSite Pathology SolutionPSY2024-12-02 View
510(k) K242512 ROCC ConsoleLLZ2024-10-24 View

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