BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardius® 2MXPO

    Reg #: 2031050 · FEI: 3001236767 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Digirad Diagnostic Imaging, LLC
    Registration Number
    2031050
    FEI Number
    3001236767
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13100 Gregg St Ste A
    City
    POWAY
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052430

    Owner / Operator

    Firm Name
    Digirad Diagnostic Imaging
    Operator Number
    9031213
    Address
    13100 Gregg Street, Suite A, --
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US
    Correspondent
    Elizabeth - Crawford

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    Cardius® 2MXPO Cardius® 2XPO SPECTpak Plus Cardius® x.act SPECTpak Cardius® 3 Cardius® 2 Cardius® 1M Cardius® 1 Cardius® 2M Cardius® 3XPO STASYS SPECTour

    Establishment Types

    Manufacture Medical Device