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Philips Medical Systems Nederland B.V.

FDA 510(k) & PMA Approved Devices — 77 products

Total Devices77
Categories11
Latest Approval2026-03-17
TypeNumberDevice NameCodeDate
510(k) K253614 EchoNavigator R5.0 QIH 2026-03-17 View
510(k) K260169 AV Cardiac CT JAK 2026-03-05 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 Upgrades LNH 2026-02-23 View
510(k) K253735 AV Vascular QIH 2026-01-22 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 3.0T MOS 2026-01-14 View
510(k) K252645 LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub DQK 2025-10-24 View
510(k) K251215 Philips IntelliSpace Cardiovascular LLZ 2025-10-02 View
510(k) K250181 AV Viewer LLZ 2025-07-15 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 Systems LNH 2025-07-11 View
510(k) K250648 Philips iCT CT system JAK 2025-06-27 View
510(k) K251397 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System LNH 2025-06-04 View
510(k) K242001 Philips VSC-MEDlib BZQ 2025-04-04 View
510(k) K243871 Philips IntelliSite Pathology Solution 5.1 PSY 2025-03-06 View
510(k) K242848 Philips IntelliSite Pathology Solution 5.1 PSY 2024-12-10 View
510(k) K241871 Philips IntelliSite Pathology Solution PSY 2024-12-02 View
510(k) K242512 ROCC Console LLZ 2024-10-24 View
510(k) K242879 dS Knee Coil 8ch 1.5T MOS 2024-10-18 View
510(k) K243033 dS Wrist coil 8ch 1.5T MOS 2024-10-18 View
510(k) K242096 dS FootAnkle Coil 8ch 1.5T MOS 2024-08-12 View
510(k) K233204 Philips IntelliSite Pathology Solution 5.1 PSY 2024-06-24 View
510(k) K233853 LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub DQK 2024-03-14 View
510(k) K232420 Zenition 30 OWB 2024-02-16 View
510(k) K232030 Ingenia Elition R5.7.1 SP4 MR Systems LNH 2023-08-02 View
510(k) K223918 AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub DQK 2023-06-08 View
510(k) K230972 Ingenia Elition and MR 7700 MR Systems LNH 2023-04-28 View
510(k) K223458 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems LNH 2023-04-06 View
510(k) K221270 EchoNavigator R4.0 LLZ 2022-05-31 View
510(k) K213583 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems LNH 2022-05-16 View
510(k) K212875 Spectral CT on Rails JAK 2022-05-13 View
510(k) K213516 Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei LNH 2022-03-03 View
510(k) K210760 Precise Image JAK 2022-01-14 View
510(k) K212673 MR 5300 LNH 2021-11-19 View
510(k) K212813 Zenition 70 OWB 2021-10-01 View
510(k) K203845 Philips IntelliSite Pathology Solution PSY 2021-09-17 View
510(k) K201573 Brain Perfusion (BP) application LLZ 2021-08-17 View
510(k) K211764 Vereos PET/CT KPS 2021-08-06 View
510(k) K210880 Vereos PET/CT KPS 2021-05-19 View
510(k) K203020 Spectral CT JAK 2021-02-26 View
510(k) K201583 SmartCT R1.0 OWB 2021-02-09 View
510(k) K203216 The Multimodality Advanced Vessel Analysis JAK 2020-11-25 View
510(k) K192914 Stimuplex Onvision System BSP 2020-05-27 View
510(k) K200917 Azurion R2.1 OWB 2020-05-01 View
510(k) K193215 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems LNH 2020-04-10 View
510(k) K200713 EchoNavigator LLZ 2020-04-09 View
510(k) K193454 IQon Spectral CT JAK 2020-01-24 View
510(k) K190461 Achieva 1.5T, 3.0T and Intera 1.5T MR Systems LNH 2019-06-04 View
510(k) K182716 Brain Perfusion (BP) application JAK 2019-05-29 View
510(k) K183063 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems LNH 2019-02-14 View
510(k) K183101 Zenition 50 OWB 2018-12-31 View
510(k) K183040 Zenition 70 OWB 2018-12-06 View
510(k) K180940 KODEX EPD System DQK 2018-10-24 View
510(k) K181479 Ingenia Ambition S and Ingenia Ambition X LNH 2018-08-03 View
510(k) K181830 Azurion R2.0 OWB 2018-08-02 View
510(k) K181177 Interventional Workspot LLZ 2018-05-31 View
510(k) K173079 Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 LNH 2018-04-04 View
510(k) K173451 Ingenia Elition S and Ingenia Elition X LNH 2018-03-20 View
510(k) K173356 Ingenia Elition S and Ingenia Elition X R5.4 LNH 2018-03-06 View
510(k) K172920 3D APT LNH 2018-01-22 View
510(k) K173467 Advanced Diffusion Analysis (ADA) application LLZ 2017-12-12 View
510(k) K172822 Azurion series R1.2 OWB 2017-11-22 View
510(k) K172307 Dynamic Coronary Roadmap 2.0 OWB 2017-10-24 View
510(k) K172174 Philips IntelliSite Pathology Solution PSY 2017-10-04 View
510(k) K170130 Dynamic Coronary Roadmap OWB 2017-06-02 View
510(k) K163250 Longitudinal Brain Imaging (LoBI) application LLZ 2017-05-11 View
510(k) DEN160056 Philips IntelliSite Pathology Solution PSY 2017-04-12 View
510(k) K162484 Lung Nodule Assessment and Comparison Option (LNA) LLZ 2017-02-23 View
510(k) K163715 Allura Xper R9 OWB 2017-01-26 View
510(k) K162931 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 LNH 2017-01-06 View
510(k) K163116 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 LNH 2017-01-06 View
510(k) K162940 MultiBand SENSE LNH 2016-12-30 View
510(k) K162955 Multi-Modality Tumor Tracking (MMTT) application LLZ 2016-12-19 View
510(k) K162859 Allura Xper FD series and Allura Xper OR Table series OWB 2016-12-02 View
510(k) K160455 AneurysmFlow OWB 2016-08-25 View
510(k) K160147 CT TrueView OWB 2016-08-10 View
510(k) K161839 2D Quantitative Analysis OWB 2016-07-29 View
510(k) K161563 Allura Xper FD series and Allura Xper OR Table series OWB 2016-07-29 View
510(k) K160315 I4 (Integrated Intelligent Imaging Informatics) system LLZ 2016-02-19 View
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