BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇬 Bulgaria

    CoLumbo

    K Number: K220497 · Decision Jun 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    216
    Applicant Total
    2
    Review Days
    121

    Basic Information

    Device Name
    CoLumbo
    K Number
    K220497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smart Soft Healthcare AD
    Date Received
    February 22, 2022
    Decision Date
    June 23, 2022
    Product Code
    QIH
    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
    QIH Automated Radiological Image Processing Software

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    Other Clearances by Smart Soft Healthcare AD

    K Number Device Name
    K250367 CoLumboX