BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    GalenTM Second ReadTM

    Reg #: 3035523362 · FEI: 3035523362 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IBEX MEDICAL ANALYTICS LTD
    Registration Number
    3035523362
    FEI Number
    3035523362
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 Rokach Blvd P.O. Box: 53169
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K241232

    Owner / Operator

    Firm Name
    Ibex Medical Analytics LTD
    Operator Number
    10092615
    Address
    101 Rokach Blvd, P.O. Box: 53169
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6153101
    Country
    IL
    Correspondent
    Yael Liebes Peer

    Products

    Device Name Product Code
    Software Algorithm Device To Assist Users In Digital Pathology QPN

    Proprietary Names

    GalenTM Second ReadTM Ibex Prostate Detect

    Establishment Types

    Manufacture Medical Device