BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Radialis PET Imager

    Reg #: 3022742930 · FEI: 3022742930 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RADIALIS INC.
    Registration Number
    3022742930
    FEI Number
    3022742930
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    290 Munro Street, Suite 1360
    City
    Thunder Bay Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K214062

    Owner / Operator

    Firm Name
    Radialis Inc.
    Operator Number
    10085216
    Address
    290 Munro Street, Suite 1300
    City
    Thunder Bay
    State
    Ontario
    Postal Code
    P7A 7T1
    Country
    CA
    Correspondent
    Ricardo Rodriguez

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

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

    Proprietary Names

    Radialis PET Imager Radialis PET Camera

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device