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

    Chest-CAD

    K Number: K210666 · Decision Jul 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    27
    Applicant Total
    4
    Review Days
    137

    Basic Information

    Device Name
    Chest-CAD
    K Number
    K210666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagen Technologies, Inc
    Date Received
    March 5, 2021
    Decision Date
    July 20, 2021
    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.

    Second Opinion® CS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Smile Dx®

    FDA 510(k)
    FDA Class 2 ·Radiology

    Second Opinion® Pediatric

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lung AI (LAI001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Second Opinion Periapical Radiolucency Contours

    FDA 510(k)
    FDA Class 2 ·Radiology

    Rayvolve LN

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

    Other Clearances by Imagen Technologies, Inc

    K Number Device Name
    K230085 Lung-CAD
    K223811 Lung-CAD
    K213353 Aorta-CAD