BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Siemens Healthcare Limited

    Reg #: 3012127758 · FEI: 3012127758 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    16

    Registration Details

    Registration Name
    Siemens Healthcare Limited
    Registration Number
    3012127758
    FEI Number
    3012127758
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1577 North Service Road East
    City
    Oakville Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K130842
    PMA Number
    P080003

    Owner / Operator

    Firm Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Operator Number
    9002915
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 6319702

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    System, Nuclear Magnetic Resonance Imaging LNH
    Digital Breast Tomosynthesis OTE
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Tomography, Computed JAK
    System, X-Ray, Mobile IZL
    Injector And Syringe, Angiographic DXT
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Catheter, Ultrasound, Intravascular OBJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Nuclear Magnetic Resonance Spectroscopic LNI

    Proprietary Names

    ALLURA XPER FD20 Software syngo MR 819 for MAGNETOM Avanto, Espree,Symphony A Tim System, Trio A Tim System, and Verio Selenia Dimensions/3Dimensions MEGALIX CAT 125/154/40/80 Hologic Selenia 2D Mammography SOMATOM Definition AS BODY 18 MR COIL 3T DRX-REVOLUTION MOBILE X-RAY SYSTEM Medrad Mark 7 Arterion Injection System MEDRAD STELLANT CT INJECTOR SYSTEM GE Optima MR 450 MEDRAD® Spectris Solaris EP MR Injection System SOMATOM Definition Flash MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE Senographe Pristina Signa Architect Discovery MR750 3T Allura FD 20 Xper Cios Alpha Acuson S2000 Diagnostic Ultrasound System Acuson S1000 Diagnostic Ultrasound System Acuson S3000 Diagnostic Ultrasound System MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Optima XR220amx Senographe Essential MAGNETOM AVANTO MR SYSTEM

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device