BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    OptiVu ROSA MxR

    K Number: K220733 · Decision Jul 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    3
    Review Days
    137

    Basic Information

    Device Name
    OptiVu ROSA MxR
    K Number
    K220733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosoft, Inc. (d/b/a Zimmer CAS)
    Date Received
    March 14, 2022
    Decision Date
    July 29, 2022
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    OR
    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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