BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hologic 3D mammogram

    Reg #: 3005496266 · FEI: 3005496266 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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

    PMA Number
    P080003

    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
    Digital Breast Tomosynthesis OTE

    Proprietary Names

    Hologic 3D mammogram SELENIA DIMENSIONS 3D SYSTEM & ACCESSORIES Genius 3D Mammography 3Dimensions System & Accessories Dimensions Access System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device