BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOLOGIC, INC.

    Reg #: 3005496266 · FEI: 3005496266 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    42
    Establishment Types
    4
    Classifications
    15

    Registration Details

    Registration Name
    HOLOGIC, INC.
    Registration Number
    3005496266
    FEI Number
    3005496266
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    600 Technology Drive
    City
    Newark
    State
    DE
    ZIP
    19702
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243341
    PMA Number
    P010025

    Owner / Operator

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

    Products

    Device Name Product Code
    Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ
    Densitometer, Bone KGI
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Mammographic IZH
    System, Image Processing, Radiological LLZ
    Cabinet, X-Ray System MWP
    Lung Computed Tomography System, Computer-Aided Detection OEB
    Camera, Scintillation (Gamma) IYX
    System, Digital Image Communications, Radiological LMD
    Digital Breast Tomosynthesis OTE
    Analyzer, Medical Image MYN
    Instrument, Biopsy KNW
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Container, Specimen, Non-Sterile NNI
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO

    Proprietary Names

    Genius AI Detection 2 APEX 2 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS Selenia Dimensions Mammography System Affirm Breast Biopsy Guidance System Affirm Prone Biopsy System Unifi Workspace Horizon DXA System FAXITRON SPECIEN RADIOGRAPHY SYSTEM Quantra Faxitron PathPlus Specimen Radiography System Genius AI Detection IMAGECHECKER CT CAD SOFTWARE SYSTEM Affirm Lateral Arm Upright Biopsy Accessory MAMMOPAD RADIOLUCENT CUSHION digital image communications, radiological MODIFIED 650 MAMMOGRAPHY SYSTEM SELENIA DIMENSIONS 3D SYSTEM & ACCESSORIES 3Dimensions System & Accessories Genius 3D Mammography Dimensions Access System Hologic 3D mammogram AFFIRM BREAST BIOPSY GUIDANCE SYSTEM ImageChecker CAD MODIFIED M-IV MAMMOGRAPHY SYSTEM Affirm® Contrast Biopsy R2 DIGITALNOW HD(DIGITALNOW HD) Brevera Breast Biopsy System with Corlumina Imaging Technology QUANTRA MULTICARE PLATINUM SYSTEM AND ACCESSORIES SecurView DX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Faxitron Core Specimen Radiography System Insight 2 Faxitron Wedge BIOLUCENT MAMMOGRAPHY CUSHION DIGITAL STEREOLOC II Trident HD Specimen Radiography System Trident Specimen Radiography System DIGITAL SPOT MAMMOGRAPHY SYSTEM Multiview CONTRAST ENHANCED DIGITAL MAMMOGRAPHY INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

    Establishment Types

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