BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    SCANORA 3D

    K Number: K110839 · Decision Jun 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    9
    Review Days
    97

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    Basic Information

    Device Name
    SCANORA 3D
    K Number
    K110839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Soredex Palodex Group OY
    Date Received
    March 25, 2011
    Decision Date
    June 30, 2011
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by Soredex Palodex Group OY

    K Number Device Name
    K073350 SCANORA 3D
    K070304 DIGORA PCT/DIGIPOD
    K063459 CRANEX NOVUS
    K043307 CRANEX D
    K040382 CRANEX BASEX D OR CRANEX EXCEL D
    K041050 DIGORA OPTIME (OR DIGORA ONTIME)
    K033755 MINRAY
    K012170 DIGORA PCT