BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    DeepXray Spina

    K Number: K253192 · Decision Jun 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    257

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    Basic Information

    Device Name
    DeepXray Spina
    K Number
    K253192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1171
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Intelligence Manifolds, Inc.
    Date Received
    September 26, 2025
    Decision Date
    June 10, 2026
    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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    Other Clearances by Alpha Intelligence Manifolds, Inc.

    K Number Device Name
    K223621 DeepXray