BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ImagenSPECT 3

    Reg #: 3004504920 · FEI: 3004504920 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
    Registration Number
    3004504920
    FEI Number
    3004504920
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4320 Wornall Rd Ste 114
    City
    KANSAS CITY
    State
    MO
    ZIP
    64111
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201933

    Owner / Operator

    Firm Name
    CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
    Operator Number
    9059156
    Address
    4320 WORNALL RD STE 114, --
    City
    Kansas City
    State
    MO
    Postal Code
    64111
    Country
    US
    Correspondent
    JAMES A CASE

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS
    System, Image Processing, Radiological LLZ

    Proprietary Names

    ImagenSPECT 3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device