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Philips Medical Systems Nederland B.V. FDA Approvals
0 new drug approvals and 43 device clearances on file. This applicant is not matched to a listed company.
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A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Zenition 30510(k)Aug 7, 2026Radiology |
| 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 3.0T510(k)Jul 30, 2026Radiology |
| 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 3.0T510(k)Jul 24, 2026Radiology |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0)510(k)May 27, 2026Radiology |
| EchoNavigator R5.0510(k)Mar 17, 2026Radiology |
| AV Cardiac CT510(k)Mar 5, 2026Radiology |
| Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades510(k)Feb 23, 2026Radiology |
| AV Vascular510(k)Jan 22, 2026Radiology |
| dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T510(k)Jan 14, 2026Radiology |
| LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub510(k)Oct 24, 2025Cardiovascular |
| Philips IntelliSpace Cardiovascular510(k)Oct 2, 2025Radiology |
| AV Viewer510(k)Jul 15, 2025Radiology |
| 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 Systems510(k)Jul 11, 2025Radiology |
| Philips iCT CT system510(k)Jun 27, 2025Radiology |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System510(k)Jun 4, 2025Radiology |
| Philips VSC-MEDlib510(k)Apr 4, 2025Anesthesiology |
| Philips IntelliSite Pathology Solution 5.1510(k)Mar 6, 2025Pathology |
| Philips IntelliSite Pathology Solution 5.1510(k)Dec 10, 2024Pathology |
| Philips IntelliSite Pathology Solution510(k)Dec 2, 2024Pathology |
| ROCC Console510(k)Oct 24, 2024Radiology |
| dS Knee Coil 8ch 1.5T510(k)Oct 18, 2024Radiology |
| dS Wrist coil 8ch 1.5T510(k)Oct 18, 2024Radiology |
| dS FootAnkle Coil 8ch 1.5T510(k)Aug 12, 2024Radiology |
| Philips IntelliSite Pathology Solution 5.1510(k)Jun 24, 2024Pathology |
| LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub510(k)Mar 14, 2024Cardiovascular |
| Zenition 30510(k)Feb 16, 2024Radiology |
| Ingenia Elition R5.7.1 SP4 MR Systems510(k)Aug 2, 2023Radiology |
| AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub510(k)Jun 8, 2023Cardiovascular |
| Ingenia Elition and MR 7700 MR Systems510(k)Apr 28, 2023Radiology |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems510(k)Apr 6, 2023Radiology |
| EchoNavigator R4.0510(k)May 31, 2022Radiology |
| Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems510(k)May 16, 2022Radiology |
| Spectral CT on Rails510(k)May 13, 2022Radiology |
| Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei510(k)Mar 3, 2022Radiology |
| Precise Image510(k)Jan 14, 2022Radiology |
| MR 5300510(k)Nov 19, 2021Radiology |
| Zenition 70510(k)Oct 1, 2021Radiology |
| Philips IntelliSite Pathology Solution510(k)Sep 17, 2021Pathology |
| Brain Perfusion (BP) application510(k)Aug 17, 2021Radiology |
| Vereos PET/CT510(k)Aug 6, 2021Radiology |
| Vereos PET/CT510(k)May 19, 2021Radiology |
| Spectral CT510(k)Feb 26, 2021Radiology |
| SmartCT R1.0510(k)Feb 9, 2021Radiology |