BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

    Reg #: 3003768277 · FEI: 3002807880 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    282
    Establishment Types
    3
    Classifications
    36

    Registration Details

    Registration Name
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Registration Number
    3003768277
    FEI Number
    3002807880
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VEENPLUIS 6
    City
    BEST Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K201389

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Maria Heiling
    Address
    3721 Valley Centre Dr. Ste. 500
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    858 2487651

    Products

    Device Name Product Code
    Table, Radiologic KXJ
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Monitor, Patient Position, Light-Beam IWE
    System, Nuclear Magnetic Resonance Imaging LNH
    Collimator, Manual, Radiographic IZX
    Collimator, Automatic, Radiographic IZW
    System, Image Processing, Radiological LLZ
    Holder, Head, Radiographic IWY
    System, X-Ray, Tomography, Computed JAK
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Wire, Guide, Catheter DQX
    Computer, Diagnostic, Programmable DQK
    Table, Operating-Room, Ac-Powered FQO
    Table, Radiographic, Non-Tilting, Powered IZZ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Coil, Magnetic Resonance, Specialty MOS
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Shield, Protective, Personnel KPY
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Injector And Syringe, Angiographic DXT
    Set, I.V. Fluid Transfer LHI
    Device, Medical Examination, Ac Powered KZF
    Test-Pattern, Radiographic IXF
    Grid, Radiographic IXJ
    Table, Radiographic, Stationary Top IXQ
    Tube Mount, X-Ray, Diagnostic IYB
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Automated Radiological Image Processing Software QIH
    Accelerator, Linear, Medical IYE
    System, Planning, Radiation Therapy Treatment MUJ
    Instrument, Quality-Assurance, Radiologic LHO
    System, X-Ray, Angiographic IZI

    Proprietary Names

    Radiologic Table Zenition 30 VARIOUS MODELS CENTERING LIGHT (OR LASER) Passive Driver 459800607782 MR Elastography System 989603026364 Active Driver 459801514303 FORMAT Collimator Family EchoNavigator R4 Neuro Head Holder Achieva Family T/R HEAD COIL 3T 4598-001-5223x SENSE FLEX L COIL 3T ODU 4522-133-1722x SENSE FLEX M COIL 3T ODU 4522-133-1721x SENSE FLEX S COIL 3T ODU 4522-133-1720x XperCT Rel. 3 Zenition 50 Ingenia Elition R5.7.1 SP4 MR Systems Azurion R2 HF GENERATOR IV 15KW CT XS Generator Velara Certeray IXION III HF GENERATOR Spellman HF generator XS-100 Generator Azurion 7 B20 Azurion 5 M12 Azurion 3 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 M20 Azurion 5 M20 Azurion 7 B12 SmartCT EchoNavigator R3 MR 7700 Upgrade to MR 7700 SmartPath to Ingenia Elition X BlueSeal SE SmartPath to MR 7700 Ingenia Ambition X Ingenia Elition X Evolution Upgrade 1.5T Upgrades dStream to R12 SmartPath to dStream for 1.5T Evolution Upgrade 3T BlueSeal XE Ingenia Elition S MR 5300 Ingenia Ambition S SmartPath to dStream for 3T LumiGuide 3D Hub LumiGuide Wire LumiGuide Equipment R2 ProxiDiagnost N90 Intera Sensation Family Equipment Rack Intera I/T MR system BuckyDiagnost: TH2, THS DigitalDiagnost C90 LUCY with HeadCoilSet Philips 3T 989603083722 LUCY with HeadCoilSet Philips 1.5T 989603083712 001014 - 2D Quantitative Analysis Table X-Ray Protec 1.5 T eCoil Imaging System for Philips Expression IP5 Information Portal Expression MR200 MRI Patient Monitoring System NiBP Cuff, Single Lumen, Thigh - 989803182681 NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211 NiBP Cuff, Single Lumen, Infant - 989803182611 NiBP Cuff, Single Lumen, Adult-L - 989803182651 NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171 NiBP Cuff, Single Lumen, Pediatric - 989803182621 NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671 NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591 NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581 NiBP Cuff, Single Lumen, Lrg Adult - 989803182661 Expression IP5 Software Upgrade - 989803197491 NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201 NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571 NiBP Cuff, Single Lumen, Adult - 989803182641 NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521 NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191 NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551 NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531 NiBP Cuff, Single Lumen, Adult, Disp - 989803182541 NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181 Wireless SpO2 Patient Module - 989803183541 NiBP Cuff, Single Lumen, Infant, Disp - 989803182511 NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561 Advanced Apps ECG Cable - 989803176381 NiBP Cuff, Single Lumen, Small Adult - 989803182631 Expression MR Wireless ECG Patient Module - 989803183661 Expression MR200 New MRI Monitor Accessories - 866177 Achieva Ingenia Ingneia CX Ingenia Ambition Intera Ingenia Elition SYN.BODY COIL 1.5T ODU 4598-005-5189x SENSE FLEX S COIL 1.5T ODU 4522-133-1719x T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x QUAD HEAD COIL 1.5T 4522-133-1727x SENSE FLEX L COIL 1.5T ODU 4522-133-1715x MRI COILS SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x SENSE SPINE COIL 1.5T ODU 4522-133-1724x SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x SENSE CARDIAC COIL 4522-133-1726x SENSE FLEX M COIL 1.5T ODU 4522-133-1717x SENSE SPINE COIL 1.5T 4522-133-1723x SHNC DRIVERBOX 1.5T 4598-000-5181x SHNC DRIVERBOX 1.5T ODU 4598-000-5182x Achieva 1.5T family Intera 1.5T family SENSE FLEX S COIL 1.5T 4522-133-1718x CIRC.COIL C3 1.5T 4598-000-5196x MICRO 23MM COIL 4598-000-5197x MICRO 47MM COIL 4598-000-5198x ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x CIRC.COIL C1 1.5T 4598-000-5184x SENSE CARDIAC COIL 4522-133-1725x SENSE FLEX M COIL 1.5T 4522-133-1716x SENSE FLEX L COIL 1.5T 4522-133-1714x Pediatric Body-Cardiac Coil 4522-150-41131 dS Ped. TorsoCardiac 8ch 1.5T 4598-000-20671 VesselNavigator CombiDiagnost R90 Medrad Mark V-Plus Injector SmartPath to dStream for XR and 3T Upgrades dStream to R5.7 Upgrades Achieva/Intera to R5.7 Ingenia 3T Achieva, Intera,&Panaroma 1T R2 ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Radiography 7300 C Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems Examination Light dS Ped. HeadSpine 8ch 1.5T 4598-000-20681 Pediatric Head-Spine Coil 4522-150-41161 Ingenia Elition X R5.4 Dynamic Coronary Roadmap 2 INgenia 1.5T CX and Ingenia 3T CX R5.3 Na-140-Flex Coil 989603031991 C-140-Flex Coil 989603031981 P-140-Flex Coil 989603029722 Knee/Foot Coil 4522-150-40972 MR-CT Roadmap Rel. 1 Allura 3D-RA Rel. 6 3D Roadmap Rel. 1 3D-RA DigitalDiagnost ProGrade SkyPlate MRE Phantom Kit BlueSeal QE Upgrades dStream to R13 Ingenia Elition and MR 7700 MR Systems Achieva 1.5T, 3T, and Intera 1.5T Sense head coil 3T Sense NV Coil 3T Zenition 70 Stentboost R4.2 Zenition 90 Ingenia 3T CX R5.4 Ingenia 1.5T Ingenia 1.5T CX Ingenia 1.5T S MR 5300 and MR 7700 R11 MR Systems MR 7700 with Distributed Multi Nuclei Ingenia 3TCX Radiological Grid RADIOGRAPHIC GRID BuckyDiagnost ProxiDiagnost N90 / Precision CRF Interventional Workspot Pediatric Body-Cardiac Coil 4522-133-18721 dS Ped. TorsoCardiac 8ch 3T 4598-000-20651 Quick Connect SpO2 Grip, Adult, 20/box - 989803166551 Quick Connect SpO2 Grip, Ped, 20/box - 989803166561 Quick Connect SpO2 Clip, Adult - 989803166531 Quick Connect SpO2 Probe, MRI - 989803161991 Quick Connect SpO2 Clip, Pediatric - 989803166541 CAB,4 LD,NEO.MRI ECG - 9222 SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501 GRIP SENSOR STARTER KIT - 989803162491 SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511 PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023 Quick Connect SpO2 Grip, Infant, 20/box - 989803166571 KIT,SAMPLE,AGENTS,3160 - 94018 Anesthetic Oxygen (O2) Sensor - 989803162051 CUFFF,CHILD,MRI,COLDER CONN - 989803169441 CAB,4 LD,MRI ECG - 9224 Quick Connect SpO2 Starter Kit - 989803167111 Quick Connect SpO2 Grip, Neo, 20/box - 989803166581 Wireless SP02 Module (Gen 2) - 989803163111 Wireless ECG Module - 989803163121 ADVANCED FILTER ECG CABLE - 989803170121 Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421 Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401 CAB,4 LD,CV MRI ECG - 9223 MRI Patient Monitoring System, Mode EmboGuide R1 EP Navigator R5 EchoNavigator Release 1 CT TrueView - 001010 XperGuide DU, DR CTR22xx Series H.T Converter Tank BV300 Spellman Monoblock XS-100 X-ray tube assembly X-Ray Tube, Brightview XCT SRO (Super Rotalix) CTR17xx Series CTR21xx Series CTxxxx Series Monoblock IXION V RO (Rotalix) SRM (Super Rotalix Metal) MRM (Maximus Rotalix Metal) IXION MONOBLOCK DRxxx Series DAxxx Series vMRC Performance CT XS Tube MRC (Maximus Rotalix Ceramic) DUxxx Series Flexibility with Headcoilset Philips1.5T 989603051092 Flexibility with Headcoilset Philips3T 989603051102 Ingenia 1.5T S - 781-347 Ingenia 1.5T - 781-341 EchoNavigator R5 DORADOnova MR3T 989603083322 989603083312 APOLLO MR3T 989603083422 989603083412 Panorama 1T Xper Information Management System Xper Flex Cardio Physiomonitoring System LumiGuide Equipment R2.1 Heart Navigator Release 2 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Trolley Acoustic Hood HA Flex Trak HA FlexTrak II Tabletop Extender FlexTrak MR-OR 3T MR-OR 1.5T Precision CRF MRCAT Pelvis / RTgo 3 Geometric QA Phantom - 459800438932 Philips DoseAware R1.1 DoseAware R2 DoseAware System WingSTEP M Low 989603083452 M STEP Base Patient Positioning Package 989603083442 Collimator IITV Square Collimator FD12 Square Collimator FD15 Collimator P225 ACS Rev 1.1 Collimator BV300 NICOL Collimator Family Square Collimator FD17 Ingenia 3T CX SENSE BREAST COIL 1.5T 7-CH Pediatric Head-Spine Coil 4522-133-18981 dS Ped. HeadSpine 8ch 3T 4598-000-20661 Philips Hemodynamic Application R1 Allura 3D-CA 3D-CA CT TrueView MRCAT Brain / RTgo 4 INgenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 Azurion series R1.2 MR-RT CouchTop MRCAT Head & Neck/RTgo 5 RT couchTop XD StentBoost Live

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Remanufacture Medical Device