BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STANDARD IMAGING, INC.

    Reg #: 2184007 · FEI: 1000115748 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    50
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    STANDARD IMAGING, INC.
    Registration Number
    2184007
    FEI Number
    1000115748
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3120 DEMING WAY
    City
    MIDDLETON
    State
    WI
    ZIP
    53562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031975

    Owner / Operator

    Firm Name
    STANDARD IMAGING, INC.
    Operator Number
    9003193
    Address
    3120 DEMING WAY, --
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Ellen M Young

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    Instrument, Quality-Assurance, Radiologic LHO
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    System, Applicator, Radionuclide, Manual IWJ
    Accessory - Film Dosimetry System MWW
    Medical Device Data System OUG
    Phantom, Anthropomorphic, Radiographic IXG
    Device, Digital Image Storage, Radiological LMB
    System, Digital Image Communications, Radiological LMD
    System, Image Processing, Radiological LLZ
    Holder, Head, Radiographic IWY
    Shield, Protective, Personnel KPY
    Source, Brachytherapy, Radionuclide KXK

    Proprietary Names

    IMSure Brachy IMSure QA TomoScanner Exradin Scintillator Detectors QA BeamChecker Plus QA StereoChecker Mammo Compression Tool MAX Elite MAX 4000 Plus Exradin Scanning Diodes SuperMAX Exradin Ion Chambers QA BeamChecker Pro CT/SIM Check Phantom MAX SD Luthmann Source QA Tool DoseView 1D TomoElectrometer HDR 1000 Plus Well Chamber IVB 1000 Well Chamber Radiation Analyzer Film Dosimetry Software QA Pilot IMSure 3D PIPSPro Software, LinacView Adaptivo Blue Water MIMI Phantom Virtual Water Reconstruction Jig RGP Phantom LUCY 3D QA Phantom IonQA Phantom Stereotactic Dose Verification Phantom IMRT Phantom LUCY EA Phantom Winston Lutz Cube Phantom IMRT Dose Verification Phantom LUCY MR Phantom ThorX Phantom ISOCube Phantom TomoPhantom Gafchromic™ QuiCk Phantom™ MIMI MR Phantom TG-142 Phantom MR Grid Phantom DoseView 3D TomoScanner 3D Multiple Needle Loading Shields HDR 1000 Plus with Xoft Insert

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)