BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Saige-Dx

    K Number: K253825 · Decision Jun 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    196

    Basic Information

    Device Name
    Saige-Dx
    K Number
    K253825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DeepHealth, Inc.
    Date Received
    December 1, 2025
    Decision Date
    June 15, 2026
    Product Code
    QDQ
    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
    QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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    Other Clearances by DeepHealth, Inc.

    K Number Device Name
    K254131 BAC
    K251873 Saige-Dx
    K243703 TechLive
    K243688 Saige-Dx (3.1.0)
    K243705 Saige-Density (2.5.0)
    K241747 Saige-Dx
    K222275 Saige-Density
    K220105 Saige-Dx
    K203517 Saige-Q