BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Histolog® Scanner (Hardware 2.4, Software 3.3)

    K Number: K241275 · Decision Aug 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    Histolog® Scanner (Hardware 2.4, Software 3.3)
    K Number
    K241275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Samantree Medical SA
    Date Received
    May 6, 2024
    Decision Date
    August 19, 2024
    Product Code
    OWN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWN Confocal Optical Imaging

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