BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Philips Medical Systems DMC GmbH

    Reg #: 3003768251 · FEI: 3003768251 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    69
    Establishment Types
    4
    Classifications
    20

    Registration Details

    Registration Name
    Philips Medical Systems DMC GmbH
    Registration Number
    3003768251
    FEI Number
    3003768251
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Roentgenstrasse 24
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K173433

    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
    Martin Pedroza
    Address
    9965 Federal Drive
    City
    Colorado Springs
    State
    CO
    ZIP
    80921
    Country
    US
    Email
    [email protected]
    Phone
    440 2197243

    Products

    Device Name Product Code
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, Image Processing, Radiological LLZ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Device, Spot-Film IXL
    Table, Radiologic KXJ
    Device, Beam Limiting, X-Ray, Diagnostic KPW
    Full Field Digital, System, X-Ray, Mammographic MUE
    Cassette, Radiographic Film IXA
    Table, Radiographic, Stationary Top IXQ
    Monitor, Patient Position, Light-Beam IWE
    System, X-Ray, Mobile IZL
    Tube Mount, X-Ray, Diagnostic IYB
    Table, Radiographic, Tilting IXR
    Grid, Radiographic IXJ
    Table, Radiographic, Non-Tilting, Powered IZZ

    Proprietary Names

    HF GENERATOR IV 15KW CT XS Generator Velara Certeray IXION III HF GENERATOR Spellman HF generator XS-100 Generator 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 ProxiDiagnost N90 PCR Eleva 1.2 DigitalDiagnost BuckyDiagnost Juno DRF Philips Radiology Smart Assistant MicroDose SI Fuji Ultima EC-MA Cassettes: CC, LC, PC, C-H, D-M, D-S DigitalDiagnost C90 VARIOUS MODELS CENTERING LIGHT (OR LASER) SkyFlow Essenta DR IntelliSpace PACS 4.X IntelliSpace Breast Film and Accessories EasyDiagnost Eleva CombiDiagnost R90 Radiography 7000 M MicroDose SI (model L50) L30 EasyDiagnost DigitalDiagnost, BuckyVision, Bucky Diagnost TH, Bucky Diagnost CS2/CS4 RALCO R302 PCR Eleva S Plus PCR Eleva Corado PCR Eleva S HI Res PCR Eleva S PCR Cosima X Eleva ProxiDiagnost N90 / Precision CRF Optimus, Velara Bucky Diagnost Family MicroDose Mammography L30 ProGrade SkyPlate Precision CRF DuoDiagnost Radiological Grid RADIOGRAPHIC GRID Radiography 7300 C BuckyDiagnost: TH2, THS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device