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

    VOXEL FLINGER(TM) 3-D IMAGING SYSTEM

    K Number: K883476 · Decision Nov 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    99

    Basic Information

    Device Name
    VOXEL FLINGER(TM) 3-D IMAGING SYSTEM
    K Number
    K883476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    REALITY IMAGING CORP.
    Date Received
    August 16, 1988
    Decision Date
    November 23, 1988
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by REALITY IMAGING CORP.

    K Number Device Name
    K912410 COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM