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

    AIBOLIT 3D+

    K Number: K222458 · Decision Jan 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    2
    Review Days
    150

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    Basic Information

    Device Name
    AIBOLIT 3D+
    K Number
    K222458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aibolit Technologies, LLC
    Date Received
    August 15, 2022
    Decision Date
    January 12, 2023
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by Aibolit Technologies, LLC

    K Number Device Name
    K211443 AIBOLIT 3D+