BEUDAMED
    FDA Enforcement Class II Terminated

    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.

    Recall: Z-0974-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0974-2013
    Event ID
    64435
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intio Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    February 26, 2013
    Classification Date
    March 20, 2013
    Termination Date
    April 17, 2013
    Address
    325 Interlocken Pkwy, N/A, Broomfield, CO, 80021-3497, United States

    Description

    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.

    Reason

    INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.

    Code Info

    INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual

    Distribution

    Nationwide Distribution including MN, FL, PA, WI, NY, and RI.

    Quantity

    7