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

    Second Opinion® Panoramic

    K Number: K250525 · Decision Nov 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    266

    Basic Information

    Device Name
    Second Opinion® Panoramic
    K Number
    K250525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pearl, Inc.
    Date Received
    February 21, 2025
    Decision Date
    November 14, 2025
    Product Code
    MYN
    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
    MYN Analyzer, Medical Image

    Similar 510(k) Clearances

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

    Velmeni for Dentists (V4D) Endo-Perio

    FDA 510(k)
    FDA Class 2 ·Radiology

    qXR-Detect

    FDA 510(k)
    FDA Class 2 ·Radiology

    Diagnocat

    FDA 510(k)
    FDA Class 2 ·Radiology

    DS Core Detect

    FDA 510(k)
    FDA Class 2 ·Radiology

    DTX Studio Assist

    FDA 510(k)
    FDA Class 2 ·Radiology

    SugarBug (1.x)

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

    Other Clearances by Pearl, Inc.

    K Number Device Name
    K243234 Second Opinion® CS
    K243989 Second Opinion® 3D
    K243230 Second Opinion® BLE
    K243893 Second Opinion® Pediatric
    K242600 Second Opinion Periapical Radiolucency Contours
    K242522 Second Opinion CC
    K210365 Second Opinion