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

    CYPHER DICOM PRINT SOLUTION

    K Number: K092280 · Decision Oct 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    CYPHER DICOM PRINT SOLUTION
    K Number
    K092280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Virtual Imaging, Inc.
    Date Received
    July 28, 2009
    Decision Date
    October 16, 2009
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

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