BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intelerad USA

    Reg #: 3022435840 · FEI: 3022435840 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    Intelerad USA
    Registration Number
    3022435840
    FEI Number
    3022435840
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    305 Church at N Hills St,, 6th Floor
    City
    Raleigh
    State
    NC
    ZIP
    27609
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123466

    Owner / Operator

    Firm Name
    Intelerad Medical Systems Incorporated
    Operator Number
    9040757
    Address
    800, boul. de Maisonneuve Est, 14th floor
    City
    MONTREAL
    State
    Quebec
    Postal Code
    H2L 4L8
    Country
    CA
    Correspondent
    Eric Llewelyn

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    System, Digital Image Communications, Radiological LMD
    System, Image Processing, Radiological LLZ

    Proprietary Names

    HealthView ECG Manager Doctors Review System IntelePACS WebPAX InteleHeart CardioPACS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility