BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Healthineers AG

    Reg #: 3002466018 · FEI: 3002466018 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    44
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    Siemens Healthineers AG
    Registration Number
    3002466018
    FEI Number
    3002466018
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROENTGENSTRASSE 19-21
    City
    KEMNATH Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K781984

    Owner / Operator

    Firm Name
    Siemens Healthineers AG
    Operator Number
    8010024
    Address
    Karlheinz-Kaske-Str. 5, --
    City
    Erlangen
    State
    DE-NOTA
    Postal Code
    91052
    Country
    DE

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard, Mailcode: 65-1A
    City
    MALVERN
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 2359839

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Device, Beam Limiting, X-Ray, Diagnostic KPW
    Table, Radiologic KXJ
    Tube Mount, X-Ray, Diagnostic IYB

    Proprietary Names

    Cios Spin (VA30G) Cios Spin (VA30) Cios Spin CIARTIC Move (VB10) Arcadis Avantic ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Bucky Wall Stand Family Cios Select (VA21) Image-Intensifier Siremobil Compact L Siremobil Compact Cios Flow Cios Connect Cios Select Cios Select VA10 Cios Alpha Cios Spin (VA31A) Arcadis Varic SIREMOBILE C06 Cios Alpha (SW VA30) Cios Select (VA20) Cios Alpha VA20 Cios Alpha VA10 Cios Select (VA21) Flat Panel Collimator AIC Family Collimator RFU Family Collimator Angio Family Collimator N Family Collimator MFD Family Collimator LFD Family Collimator ML03 Collimator SFD Family Collimator N / N II Family Collimator CARD Family Collimator ML02 Family Collimator Mammo Family Collimator Mobile-C Family Cios Select (VA21) Flat Panel System Cios Select Diamond Cios Select Flat Panel (VA21F) RAD Table N Family / Detector Bucky Family / Table Family Tube stand 3D V Family Cios Alpha (VA30G) Cios Fusion Cios Select (VA21) Image Intensifier

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198