Philips Medical Systems Nederland B.V.
107 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| 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 3.0T (K262330) | Philips Medical Systems Nederland B.V. | 2026-07-30 |
| 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 3.0T (K262294) | Philips Medical Systems Nederland B.V. | 2026-07-24 |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0) (K260207) | Philips Medical Systems Nederland B.V. | 2026-05-27 |
| EchoNavigator R5.0 (K253614) | Philips Medical Systems Nederland B.V. | 2026-03-17 |
| AV Cardiac CT (K260169) | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (K253648) | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| AV Vascular (K253735) | Philips Medical Systems Nederland B.V. | 2026-01-22 |
| dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (K254190) | Philips Medical Systems Nederland B.V. | 2026-01-14 |
| LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (K252645) | Philips Medical Systems Nederland B.V. | 2025-10-24 |
| Philips IntelliSpace Cardiovascular (K251215) | Philips Medical Systems Nederland B.V. | 2025-10-02 |
| AV Viewer (K250181) | Philips Medical Systems Nederland B.V. | 2025-07-15 |
| 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 (K251808) | Philips Medical Systems Nederland B.V. | 2025-07-11 |
| Philips iCT CT system (K250648) | Philips Medical Systems Nederland B.V. | 2025-06-27 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397) | Philips Medical Systems Nederland B.V. | 2025-06-04 |
| Philips VSC-MEDlib (K242001) | Philips Medical Systems Nederland B.V. | 2025-04-04 |
| Philips IntelliSite Pathology Solution 5.1 (K243871) | Philips Medical Systems Nederland B.V. | 2025-03-06 |
| Philips IntelliSite Pathology Solution 5.1 (K242848) | Philips Medical Systems Nederland B.V. | 2024-12-10 |
| Philips IntelliSite Pathology Solution (K241871) | Philips Medical Systems Nederland B.V. | 2024-12-02 |
| ROCC Console (K242512) | Philips Medical Systems Nederland B.V. | 2024-10-24 |
| dS Wrist coil 8ch 1.5T (K243033) | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| dS Knee Coil 8ch 1.5T (K242879) | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| dS FootAnkle Coil 8ch 1.5T (K242096) | Philips Medical Systems Nederland B.V. | 2024-08-12 |
| Philips IntelliSite Pathology Solution 5.1 (K233204) | Philips Medical Systems Nederland B.V. | 2024-06-24 |
| LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (K233853) | Philips Medical Systems Nederland B.V. | 2024-03-14 |
| Zenition 30 (K232420) | Philips Medical Systems Nederland B.V. | 2024-02-16 |
| Ingenia Elition R5.7.1 SP4 MR Systems (K232030) | Philips Medical Systems Nederland B.V. | 2023-08-02 |
| AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (K223918) | Philips Medical Systems Nederland B.V. | 2023-06-08 |
| Ingenia Elition and MR 7700 MR Systems (K230972) | Philips Medical Systems Nederland B.V. | 2023-04-28 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems (K223458) | Philips Medical Systems Nederland B.V. | 2023-04-06 |
| EchoNavigator R4.0 (K221270) | Philips Medical Systems Nederland B.V. | 2022-05-31 |
| Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K213583) | Philips Medical Systems Nederland B.V. | 2022-05-16 |
| Spectral CT on Rails (K212875) | Philips Medical Systems Nederland B.V. | 2022-05-13 |
| Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei (K213516) | Philips Medical Systems Nederland B.V. | 2022-03-03 |
| Precise Image (K210760) | Philips Medical Systems Nederland B.V. | 2022-01-14 |
| MR 5300 (K212673) | Philips Medical Systems Nederland B.V. | 2021-11-19 |
| Zenition 70 (K212813) | Philips Medical Systems Nederland B.V. | 2021-10-01 |
| Philips IntelliSite Pathology Solution (K203845) | Philips Medical Systems Nederland B.V. | 2021-09-17 |
| Brain Perfusion (BP) application (K201573) | Philips Medical Systems Nederland B.V. | 2021-08-17 |
| Vereos PET/CT (K211764) | Philips Medical Systems Nederland B.V. | 2021-08-06 |
| Vereos PET/CT (K210880) | Philips Medical Systems Nederland B.V. | 2021-05-19 |
| Spectral CT (K203020) | Philips Medical Systems Nederland B.V. | 2021-02-26 |
| SmartCT R1.0 (K201583) | Philips Medical Systems Nederland B.V. | 2021-02-09 |
| The Multimodality Advanced Vessel Analysis (K203216) | Philips Medical Systems Nederland B.V. | 2020-11-25 |
| Stimuplex Onvision System (K192914) | Philips Medical Systems Nederland B.V. | 2020-05-27 |
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |
| Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215) | Philips Medical Systems Nederland B.V. | 2020-04-10 |
| EchoNavigator (K200713) | Philips Medical Systems Nederland B.V. | 2020-04-09 |
| IQon Spectral CT (K193454) | Philips Medical Systems Nederland B.V. | 2020-01-24 |
| Achieva 1.5T, 3.0T and Intera 1.5T MR Systems (K190461) | Philips Medical Systems Nederland B.V. | 2019-06-04 |
| Brain Perfusion (BP) application (K182716) | Philips Medical Systems Nederland B.V. | 2019-05-29 |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) | Philips Medical Systems Nederland B.V. | 2019-02-14 |
| Zenition 50 (K183101) | Philips Medical Systems Nederland B.V. | 2018-12-31 |
| Zenition 70 (K183040) | Philips Medical Systems Nederland B.V. | 2018-12-06 |
| KODEX EPD System (K180940) | Philips Medical Systems Nederland B.V. | 2018-10-24 |
| Ingenia Ambition S and Ingenia Ambition X (K181479) | Philips Medical Systems Nederland B.V. | 2018-08-03 |
| Azurion R2.0 (K181830) | Philips Medical Systems Nederland B.V. | 2018-08-02 |
| Interventional Workspot (K181177) | Philips Medical Systems Nederland B.V. | 2018-05-31 |
| Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (K173079) | Philips Medical Systems Nederland B.V. | 2018-04-04 |
| Ingenia Elition S and Ingenia Elition X (K173451) | Philips Medical Systems Nederland B.V. | 2018-03-20 |
| Ingenia Elition S and Ingenia Elition X R5.4 (K173356) | Philips Medical Systems Nederland B.V. | 2018-03-06 |
| 3D APT (K172920) | Philips Medical Systems Nederland B.V. | 2018-01-22 |
| Advanced Diffusion Analysis (ADA) application (K173467) | Philips Medical Systems Nederland B.V. | 2017-12-12 |
| Azurion series R1.2 (K172822) | Philips Medical Systems Nederland B.V. | 2017-11-22 |
| Dynamic Coronary Roadmap 2.0 (K172307) | Philips Medical Systems Nederland B.V. | 2017-10-24 |
| Philips IntelliSite Pathology Solution (K172174) | Philips Medical Systems Nederland B.V. | 2017-10-04 |
| Dynamic Coronary Roadmap (K170130) | Philips Medical Systems Nederland B.V. | 2017-06-02 |
| Longitudinal Brain Imaging (LoBI) application (K163250) | Philips Medical Systems Nederland B.V. | 2017-05-11 |
| Philips IntelliSite Pathology Solution (DEN160056) | Philips Medical Systems Nederland B.V. | 2017-04-12 |
| Lung Nodule Assessment and Comparison Option (LNA) (K162484) | Philips Medical Systems Nederland B.V. | 2017-02-23 |
| Allura Xper R9 (K163715) | Philips Medical Systems Nederland B.V. | 2017-01-26 |
| Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 (K162931) | Philips Medical Systems Nederland B.V. | 2017-01-06 |
| Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116) | Philips Medical Systems Nederland B.V. | 2017-01-06 |
| MultiBand SENSE (K162940) | Philips Medical Systems Nederland B.V. | 2016-12-30 |
| Multi-Modality Tumor Tracking (MMTT) application (K162955) | Philips Medical Systems Nederland B.V. | 2016-12-19 |
| Allura Xper FD series and Allura Xper OR Table series (K162859) | Philips Medical Systems Nederland B.V. | 2016-12-02 |
| AneurysmFlow (K160455) | Philips Medical Systems Nederland B.V. | 2016-08-25 |
| CT TrueView (K160147) | Philips Medical Systems Nederland B.V. | 2016-08-10 |
| 2D Quantitative Analysis (K161839) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| I4 (Integrated Intelligent Imaging Informatics) system (K160315) | Philips Medical Systems Nederland B.V. | 2016-02-19 |
| VesselNavigator Rel. 1.0 (K151598) | Philips Medical Systems Nederland B.V. | 2015-08-17 |
| O-MAR (K143253) | Philips Medical Systems Nederland B.V. | 2015-04-09 |
| EmboGuide (K142273) | Philips Medical Systems Nederland B.V. | 2015-01-30 |
| EP NAVIGATOR REL. 5.0 (K142126) | Philips Medical Systems Nederland B.V. | 2014-12-09 |
| VERADIUS (K133819) | Philips Medical Systems Nederland B.V. | 2014-07-10 |
| MR ELASTOGRAPHY (K140666) | Philips Medical Systems Nederland B.V. | 2014-06-13 |
| HEARTNAVIGATOR RELEASE 2.0 (K140138) | Philips Medical Systems Nederland B.V. | 2014-06-10 |
| ALLURA XPER FD; OR TABLE (K133292) | Philips Medical Systems Nederland B.V. | 2014-03-05 |
| MDIXON-QUANT (K133526) | Philips Medical Systems Nederland B.V. | 2014-02-12 |
| 2D PERFUSION (K132147) | Philips Medical Systems Nederland B.V. | 2013-12-16 |
| STENTBOOST REL. 4 (K132305) | Philips Medical Systems Nederland B.V. | 2013-10-30 |
| PHILIPS HERCEPTEST DIGITAL SCORE (K130021) | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| XPERCT REL. 3 (K130893) | Philips Medical Systems Nederland B.V. | 2013-09-06 |
| SWIP (K131241) | Philips Medical Systems Nederland B.V. | 2013-08-30 |
| XPERGUIDE (K131263) | Philips Medical Systems Nederland B.V. | 2013-07-24 |
| ALLURACLARITY XPER FD SERIES X-RAY SYSTEM (K130638) | Philips Medical Systems Nederland B.V. | 2013-06-28 |
| MR PERMEABILITY (K130278) | Philips Medical Systems Nederland B.V. | 2013-05-29 |
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 (K121772) | Philips Medical Systems Nederland B.V. | 2013-03-21 |
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