Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Medical Systems Nederland B.V. · Predicate Candidate Screening
107 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
243 days90th percentile
107clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 | 221 | 0 |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Br | Philips Medical Systems Nederland B.V. | 2026-07-30 | 21 | 0 |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/ | Philips Medical Systems Nederland B.V. | 2026-07-24 | 17 | 0 |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | 2026-05-27 | 124 | 0 |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | 2026-03-17 | 119 | 0 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 | 44 | 0 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S | Philips Medical Systems Nederland B.V. | 2026-02-23 | 95 | 0 |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | 2026-01-22 | 59 | 0 |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS H | Philips Medical Systems Nederland B.V. | 2026-01-14 | 22 | 0 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025-10-24 | 64 | 0 |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | 2025-10-02 | 167 | 0 |
| K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | 2025-07-15 | 174 | 0 |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX | Philips Medical Systems Nederland B.V. | 2025-07-11 | 29 | 7 |
| K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | 2025-06-27 | 115 | 2 |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, Blue | Philips Medical Systems Nederland B.V. | 2025-06-04 | 29 | 8 |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025-04-04 | 269 | 0 |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2025-03-06 | 79 | 0 |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-12-10 | 81 | 0 |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2024-12-02 | 158 | 0 |
| K242512 | ROCC Console | Philips Medical Systems Nederland B.V. | 2024-10-24 | 62 | 0 |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 | 21 | 0 |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 | 25 | 0 |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-08-12 | 25 | 0 |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | 2024-06-24 | 270 | 0 |
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2024-03-14 | 100 | 0 |
| K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024-02-16 | 189 | 0 |
| K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | Philips Medical Systems Nederland B.V. | 2023-08-02 | 26 | 1 |
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D | Philips Medical Systems Nederland B.V. | 2023-06-08 | 161 | 0 |
| K230972 | Ingenia Elition and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | 2023-04-28 | 23 | 13 |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5 | Philips Medical Systems Nederland B.V. | 2023-04-06 | 141 | 8 |
| K221270 | EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. | 2022-05-31 | 29 | 0 |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Am | Philips Medical Systems Nederland B.V. | 2022-05-16 | 185 | 31 |
| K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | 2022-05-13 | 246 | 6 |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 w | Philips Medical Systems Nederland B.V. | 2022-03-03 | 120 | 39 |
| K210760 | Precise Image | Philips Medical Systems Nederland B.V. | 2022-01-14 | 305 | 0 |
| K212673 | MR 5300 | Philips Medical Systems Nederland B.V. | 2021-11-19 | 87 | 17 |
| K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021-10-01 | 28 | 4 |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021-09-17 | 260 | 0 |
| K201573 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | 2021-08-17 | 432 | 0 |
| K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021-08-06 | 59 | 0 |
| K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021-05-19 | 56 | 0 |
| K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021-02-26 | 147 | 6 |
| K201583 | SmartCT R1.0 | Philips Medical Systems Nederland B.V. | 2021-02-09 | 243 | 0 |
| K203216 | The Multimodality Advanced Vessel Analysis | Philips Medical Systems Nederland B.V. | 2020-11-25 | 23 | 0 |
| K192914 | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | 2020-05-27 | 225 | 0 |
| K200917 | Azurion R2.1 | Philips Medical Systems Nederland B.V. | 2020-05-01 | 25 | 63 |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and I | Philips Medical Systems Nederland B.V. | 2020-04-10 | 141 | 141 |
| K200713 | EchoNavigator | Philips Medical Systems Nederland B.V. | 2020-04-09 | 22 | 0 |
| K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020-01-24 | 42 | 3 |
| K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | Philips Medical Systems Nederland B.V. | 2019-06-04 | 98 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda