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

    DV. Target

    K Number: K202928 · Decision Apr 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    185

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    Basic Information

    Device Name
    DV. Target
    K Number
    K202928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deepvoxel, Inc.
    Date Received
    September 29, 2020
    Decision Date
    April 2, 2021
    Product Code
    QKB
    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
    QKB Radiological Image Processing Software For Radiation Therapy

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