BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Digirad Diagnostic Imaging, LLC

    Reg #: 2031050 · FEI: 3001236767 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Digirad Diagnostic Imaging, LLC
    Registration Number
    2031050
    FEI Number
    3001236767
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13100 Gregg St Ste A
    City
    POWAY
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K961104

    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
    Camera, Scintillation (Gamma) IYX
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    ergo¿ Imaging System 2020tc Imaging System Notebook Imager Cardius® 1 SPECTour SPECTpak Cardius® 3XPO Cardius® 2M STASYS Cardius® 1M SPECTpak Plus Cardius® 2 Cardius® x.act Cardius® 2MXPO Cardius® 3 Cardius® 2XPO Ergo Imaging System

    Establishment Types

    Manufacture Medical Device