BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMAGECHECKER CT CAD SOFTWARE SYSTEM

    Reg #: 3005496266 · FEI: 3005496266 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HOLOGIC, INC.
    Registration Number
    3005496266
    FEI Number
    3005496266
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Technology Drive
    City
    Newark
    State
    DE
    ZIP
    19702
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043617

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Lung Computed Tomography System, Computer-Aided Detection OEB

    Proprietary Names

    IMAGECHECKER CT CAD SOFTWARE SYSTEM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device