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

    Saige-Dx

    K Number: K251873 · Decision Aug 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    54

    Basic Information

    Device Name
    Saige-Dx
    K Number
    K251873
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DeepHealth, Inc.
    Date Received
    June 18, 2025
    Decision Date
    August 11, 2025
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QDQ), ordered by most recent decision date.

    Saige-Dx

    FDA 510(k)
    FDA Class 2 ·Radiology

    DeepHealth ProstateAI

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lunit INSIGHT MMG (v1.1.10)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lunit INSIGHT DBT (V1.2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Median LCS (internal name) / eyonis LCS (trade name) (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Genius AI Detection 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by DeepHealth, Inc.

    K Number Device Name
    K253825 Saige-Dx
    K254131 BAC
    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