Data / Medical devices / Netherlands / Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V.: FDA-registered device maker in BEST Noord-Brabant, Netherlands, 50 510(k) clearances
Philips Medical Systems Nederland B.V. is registered with the FDA (registration 3042175844) in BEST Noord-Brabant, Netherlands. It lists 12 device types. The FDA files 50 510(k) clearances under its listings, the newest dated August 7, 2026. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3042175844
- Address
- Veenpluis 6, BEST Noord-Brabant, Netherlands, 5684 PC
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 21, 2006
- Registered through
- 2026
- Brand names listed
- 001014 - 2D Quantitative Analysis, 3D Roadmap Rel. 1, 3D-CA, 3D-RA, 722026 - Allura Xper FD10, 722027 - Allura Xper FD10/10, 722028 - Allura Xper FD20, 722029 - Allura Xper FD20/10 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Collimator, Automatic, Radiographic | IZW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Collimator, Manual, Radiographic | IZX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Table, Radiologic | KXJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2026 | K254205 | Zenition 30 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 10, 2026 | K253670 | SmartCT (R3.0 (L10)) | OWB | Substantially Equivalent | Philips Medical Systems B.V. | accessdata.fda.gov |
| March 17, 2026 | K253614 | EchoNavigator R5.0 | QIH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 16, 2026 | K254186 | Azurion R3.1 | OWB | Substantially Equivalent | Philips Medical Systems B.V. | accessdata.fda.gov |
| October 24, 2025 | K251827 | Azurion R3.1 | OWB | Substantially Equivalent | Philips Medical Systems B.V. | accessdata.fda.gov |
| May 22, 2024 | K240224 | Zenition 90 | OWB | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| February 16, 2024 | K232420 | Zenition 30 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 31, 2022 | K221270 | EchoNavigator R4.0 | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 1, 2021 | K212813 | Zenition 70 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| February 9, 2021 | K201583 | SmartCT R1.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 1, 2020 | K200917 | Azurion R2.1 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 9, 2020 | K200713 | EchoNavigator | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 31, 2018 | K183101 | Zenition 50 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 6, 2018 | K183040 | Zenition 70 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| September 7, 2018 | K181311 | Philips Hemodynamic Application R1.0 | MWI | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| August 2, 2018 | K181830 | Azurion R2.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 31, 2018 | K181177 | Interventional Workspot | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| November 22, 2017 | K172822 | Azurion series R1.2 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 24, 2017 | K172307 | Dynamic Coronary Roadmap 2.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 7, 2017 | K170144 | StentBoost Live | OWB | Substantially Equivalent | Philips Medical Stystems Nederland BV | accessdata.fda.gov |
| January 26, 2017 | K163715 | Allura Xper R9 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 2, 2016 | K162859 | Allura Xper FD series and Allura Xper OR Table series | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| November 23, 2016 | K162148 | Allura Xper R9 | OWB | Substantially Equivalent | Philips Medical Systems Nethrlands BV | accessdata.fda.gov |
| August 25, 2016 | K160455 | AneurysmFlow | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 10, 2016 | K160147 | CT TrueView | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 29, 2016 | K161839 | 2D Quantitative Analysis | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 29, 2016 | K161563 | Allura Xper FD series and Allura Xper OR Table series | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 17, 2015 | K151598 | VesselNavigator Rel. 1.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 30, 2015 | K142273 | EmboGuide | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 9, 2014 | K142126 | EP NAVIGATOR REL. 5.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 22, 2014 | K142708 | VERADIUS UNITY | OWB | Substantially Equivalent | Philips Medical Systems Nethrlands BV | accessdata.fda.gov |
| August 19, 2014 | K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES | OWB | Substantially Equivalent | Philips Medical Systems Netherland BV | accessdata.fda.gov |
| July 10, 2014 | K133819 | VERADIUS | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 10, 2014 | K140138 | HEARTNAVIGATOR RELEASE 2.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 5, 2014 | K133292 | ALLURA XPER FD; OR TABLE | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 30, 2013 | K132305 | STENTBOOST REL. 4 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| September 6, 2013 | K130893 | XPERCT REL. 3 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 24, 2013 | K131263 | XPERGUIDE | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 28, 2013 | K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 21, 2013 | K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES | IZI | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 21, 2013 | K121772 | ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 26, 2012 | K121781 | ECHONAVIGATOR RELEASE 1 | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 9, 2010 | K102005 | ALLURA XPER OR TABLE SERIES | OWB | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| March 16, 2009 | K090590 | VERADIUS, MODEL 718-130 | OWB | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| September 27, 2004 | K042334 | ALLURA 3D-CA, RELEASE 1 | LLZ | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| July 30, 2004 | K041949 | ALLURA XPER FD10 | IZI | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| December 9, 2003 | K033737 | ALLURA XPER FD20 | OWB | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| July 21, 2003 | K031597 | DUNLEE FORMAT COLLIMATOR FAMILY | IZW | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| May 13, 2003 | K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 | IZI | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| March 12, 2001 | K010435 | PHILIPS BV PULSERA/ENDURA | OWB | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 6, 2026 | 99939 | Not yet classified | Open, Classified | Philips Azurion 3 M12. Model Numbers: 722063, 722221. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired image | accessdata.fda.gov |
| July 16, 2026 | 99423 | Class II | Ongoing | 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 | Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications | accessdata.fda.gov |
| July 16, 2026 | 99422 | Class II | Ongoing | 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 are distributed only in C | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications | accessdata.fda.gov |
| June 29, 2026 | 99378 | Class II | Ongoing | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system. | Firmware issue potentially leading to loss of geometry movements. | accessdata.fda.gov |
| June 17, 2026 | 99313 | Class II | Ongoing | 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: 722033. 3. Allura Xper FD10/ | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | accessdata.fda.gov |
| April 30, 2026 | 98826 | Class II | Ongoing | 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), Azurion 7 B20 (7220 | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss | accessdata.fda.gov |
| April 28, 2026 | 98812 | Class II | Ongoing | 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. 2. Azurion 3 M15; Mo | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. | accessdata.fda.gov |
| April 28, 2026 | 98801 | Class II | Ongoing | 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, 722224). | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays t | accessdata.fda.gov |
| March 31, 2026 | 98748 | Class II | Ongoing | 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, 722232, 722281), Azurion | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. | accessdata.fda.gov |
| March 3, 2026 | 98434 | Class II | Ongoing | Allura Xper FD10C; System Code: 722001 | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | accessdata.fda.gov |
| December 7, 2023 | 98977 | Class II | Ongoing | 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 | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Angiographic
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Automated Radiological Image Processing Software
- All makers of Collimator, Automatic, Radiographic
Updated October 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.