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

    Caption Guidance

    K Number: DEN190040 · Decision Feb 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    Caption Guidance
    K Number
    DEN190040
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.2100
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Bay Labs, Inc.
    Date Received
    August 27, 2019
    Decision Date
    February 7, 2020
    Product Code
    QJU
    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
    QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence

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