BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    OptimMRI (v2)

    K Number: K242054 · Decision Aug 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    OptimMRI (v2)
    K Number
    K242054
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rebrain, Sas
    Date Received
    July 15, 2024
    Decision Date
    August 12, 2024
    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 Rebrain, Sas

    K Number Device Name
    K230150 OptimMRI