BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OsteoSight™ Hip (v1)

    K Number: K251408 · Decision Sep 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    OsteoSight™ Hip (v1)
    K Number
    K251408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1171
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Naitive Technologies, Ltd.
    Date Received
    May 6, 2025
    Decision Date
    September 2, 2025
    Product Code
    SAO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

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