Company ยท NL
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
107510(k) clearances (9 in 12 months)
218recalls (84 in 12 months)
193recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 223 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 41 |
| LLZ | System, Image Processing, Radiological | 22 |
| JAK | System, X-Ray, Tomography, Computed | 9 |
| PSY | Whole Slide Imaging System | 7 |
| MOS | Coil, Magnetic Resonance, Specialty | 6 |
| DQK | Computer, Diagnostic, Programmable | 4 |
| IZI | System, X-Ray, Angiographic | 2 |
| KPR | System, X-Ray, Stationary | 2 |
| KPS | System, Tomography, Computed, Emission | 2 |
| QIH | Automated Radiological Image Processing Software | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| BZQ | Monitor, Breathing Frequency | 1 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
| OEO | Automated Digital Image Manual Interpretation Microscope | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K254205 | Zenition 30 Philips Medical Systems Nederland B.V., NL | OWB |
| Jul 30, 2026 | 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 16 Philips Medical Systems Nederland B.V., NL | MOS |
| Jul 24, 2026 | 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 Extre Philips Medical Systems Nederland B.V., NL | MOS |
| May 27, 2026 | K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) Philips Medical Systems Nederland B.V., NL | MUJ |
| Mar 17, 2026 | K253614 | EchoNavigator R5.0 Philips Medical Systems Nederland B.V., NL | QIH |
| Mar 5, 2026 | K260169 | AV Cardiac CT Philips Medical Systems Nederland B.V., NL | JAK |
| Feb 23, 2026 | K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems includ Philips Medical Systems Nederland B.V., NL | LNH |
| Jan 22, 2026 | K253735 | AV Vascular Philips Medical Systems Nederland B.V., NL | QIH |
| Jan 14, 2026 | 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 Philips Medical Systems Nederland B.V., NL | MOS |
| Oct 24, 2025 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub Philips Medical Systems Nederland B.V., NL | DQK |
| Oct 2, 2025 | K251215 | Philips IntelliSpace Cardiovascular Philips Medical Systems Nederland B.V., NL | LLZ |
| Jul 15, 2025 | K250181 | AV Viewer Philips Medical Systems Nederland B.V., NL | LLZ |
| Jul 11, 2025 | K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ing Philips Medical Systems Nederland B.V., NL | LNH |
| Jun 27, 2025 | K250648 | Philips iCT CT system Philips Medical Systems Nederland B.V., IL | JAK |
| Jun 4, 2025 | K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System Philips Medical Systems Nederland B.V., NL | LNH |
| Apr 4, 2025 | K242001 | Philips VSC-MEDlib Philips Medical Systems Nederland B.V., NL | BZQ |
| Mar 6, 2025 | K243871 | Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V., NL | PSY |
| Dec 10, 2024 | K242848 | Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V., NL | PSY |
| Dec 2, 2024 | K241871 | Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., NL | PSY |
| Oct 24, 2024 | K242512 | ROCC Console Philips Medical Systems Nederland B.V., NL | LLZ |
| Oct 18, 2024 | K243033 | dS Wrist coil 8ch 1.5T Philips Medical Systems Nederland B.V., NL | MOS |
| Oct 18, 2024 | K242879 | dS Knee Coil 8ch 1.5T Philips Medical Systems Nederland B.V., NL | MOS |
| Aug 12, 2024 | K242096 | dS FootAnkle Coil 8ch 1.5T Philips Medical Systems Nederland B.V., NL | MOS |
| Jun 24, 2024 | K233204 | Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V., NL | PSY |
| Mar 14, 2024 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub Philips Medical Systems Nederland B.V., NL | DQK |
| Feb 16, 2024 | K232420 | Zenition 30 Philips Medical Systems Nederland B.V., NL | OWB |
| Aug 2, 2023 | K232030 | Ingenia Elition R5.7.1 SP4 MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| Jun 8, 2023 | K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub Philips Medical Systems Nederland B.V., NL | DQK |
| Apr 28, 2023 | K230972 | Ingenia Elition and MR 7700 MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| Apr 6, 2023 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| May 31, 2022 | K221270 | EchoNavigator R4.0 Philips Medical Systems Nederland B.V., NL | LLZ |
| May 16, 2022 | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| May 13, 2022 | K212875 | Spectral CT on Rails Philips Medical Systems Nederland B.V., NL | JAK |
| Mar 3, 2022 | K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei Philips Medical Systems Nederland B.V., NL | LNH |
| Jan 14, 2022 | K210760 | Precise Image Philips Medical Systems Nederland B.V., NL | JAK |
| Nov 19, 2021 | K212673 | MR 5300 Philips Medical Systems Nederland B.V., NL | LNH |
| Oct 1, 2021 | K212813 | Zenition 70 Philips Medical Systems Nederland B.V., NL | OWB |
| Sep 17, 2021 | K203845 | Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., NL | PSY |
| Aug 17, 2021 | K201573 | Brain Perfusion (BP) application Philips Medical Systems Nederland B.V., NL | LLZ |
| Aug 6, 2021 | K211764 | Vereos PET/CT Philips Medical Systems Nederland B.V., NL | KPS |
| May 19, 2021 | K210880 | Vereos PET/CT Philips Medical Systems Nederland B.V., NL | KPS |
| Feb 26, 2021 | K203020 | Spectral CT Philips Medical Systems Nederland B.V., NL | JAK |
| Feb 9, 2021 | K201583 | SmartCT R1.0 Philips Medical Systems Nederland B.V., NL | OWB |
| Nov 25, 2020 | K203216 | The Multimodality Advanced Vessel Analysis Philips Medical Systems Nederland B.V., NL | JAK |
| May 27, 2020 | K192914 | Stimuplex Onvision System Philips Medical Systems Nederland B.V., NL | BSP |
| May 1, 2020 | K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., NL | OWB |
| Apr 10, 2020 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| Apr 9, 2020 | K200713 | EchoNavigator Philips Medical Systems Nederland B.V., NL | LLZ |
| Jan 24, 2020 | K193454 | IQon Spectral CT Philips Medical Systems Nederland B.V., NL | JAK |
| Jun 4, 2019 | K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
Newest 50 of 107.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion S. Model Number: 722285. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M12. Model Numbers: 722078, 722223. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B20. Model Numbers: 722068, 722226. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B12. Model Numbers: 722067, 722225. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M20. Model Numbers: 722228, 722281. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M12. Model Number: 722227. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M12. Model Numbers: 722063, 722221. Open, Classified |
OWB | K172822 K181830 +1 |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system Open, Classified |
OWB | K200917 |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar Open, Classified |
OWB | K163715 K172822 +1 |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058.
Interventional fluoroscopic x-ray system. Open, Classified |
OWB | K133292 K141979 +2 |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400.
Interventional Fluoroscopic X-Ray System. Open, Classified |
OWB | K102005 K130638 +4 |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion under the following System Descriptions and corresponding model numbers:
1. Azurion 3 M12; Model Numbers: 722063, 722221.
2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.
Open, Classified |
OWB | K172822 K181830 +1 |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura under the following System Descriptions and corresponding model numbers:
1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026.
2. Allura Xper FD10 OR Table; Model Number: 7220 Open, Classified |
OWB | K102005 K130638 +3 |
| Jun 16, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD Open, Classified |
OWB | K102005 K130638 +4 |
| Jun 16, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips MultiDiagnost Eleva with the following Model Numbers:
Model # 708032 for MultiDiagnost Eleva;
Model # 708034 for MultiDiagnost Eleva with Flat Detector;
Model # 708036 for MultiDiagnost Eleva Open, Classified |
IZI | K023441 K050151 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| May 28, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper Open, Classified |
OWB | K102005 K130638 +4 |
| May 28, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Open, Classified |
OWB | K102005 K130638 +4 |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers.
1. Azurion 3 M12; Model Numbers: 722063, 722229 Open, Classified |
OWB | K172822 K181830 +1 |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044 Open, Classified |
OWB | None listed |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Open, Classified |
OWB | None listed |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, Open, Classified |
OWB | None listed |
| May 12, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 7222 Open, Classified |
OWB | K172822 K181830 +1 |
| Apr 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips AneurysmFlow. Model Number: 001015.
AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA dat Open, Classified |
LLZ | K160455 |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Vue Motion V12. Product Number: 1017979. Open, Classified |
LLZ | K151774 |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M20;
System Code: (1)722228, (2)722232, (3) 722281 (OUS only); Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 5 M12;
System Code: (1)722227, (2)722231; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20;
System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M12;
System Code: (1)722078, (2)722223, (3)722233; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B20;
System Code: (1)722068, (2)722226, (3)722236; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B12;
System Code: (1)722067, (2)722225, (3)722235; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M15;
System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M12;
System Code: (1)722063, (2)722221, (3)722229; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/15 OR Table;
System Code: 722059; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/15;
System Code: 722058; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/20 OR Table;
System Code: 722039; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/20;
System Code: 722038; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/10;
System Code: 722029; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA Xper FD10 OR Table;
System Code: (1) 722022, (2)722033; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA Xper FD20 Biplane OR Table;
System Code: (1) 722020, (2)722025; Open, Classified |
OWB | None listed |
| Mar 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA Xper FD20 OR Table;
System Code: (1) 722015, (2)722023, (3)722035; Open, Classified |
OWB | None listed |
Newest 50 of 218.