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510(k) Data Aggregation

    K Number
    K050862
    Device Name
    3TP WORKSPACE
    Manufacturer
    3TP LLC
    Date Cleared
    2005-07-25

    (111 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    3TP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Workspace is intended for use in conjunction with 3TP's proprietary post processing pharmacokinetic analysis software (FDA 510(k) number: K03150) to provide additional mathematical and/or statistical information specific to a particular region within a 3TP color-coded image. The Workspace does not change the original 3TP Software algorithm or the image series produced by the 3TP The Workspace supports the analysis and presentation of datasets algorithm. generated by 3TP Software algorithm and incorporates the following functions: Pixel of Interest curve (POI), Region of Interest curve (ROI), Report Card, Volume Calculation, 3TP Histogram, and 3-D visualization of 3TP data series.
    Device Description
    3TP Workspace is intended to be used as post processing software designed to receive 3TP specific series and provide additional tools to analyze those 3TP series. 3TP itself, supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images.
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    K Number
    K031350
    Device Name
    3TP SOFTWARE OPTION
    Manufacturer
    3TP LLC
    Date Cleared
    2003-06-23

    (55 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    3TP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies.
    Device Description
    The 3TP Software Option is a post processing software module. The 3TP Software Option supports the evaluation of dynamic MR data gathered after the injection of a bolus of a contrast agent. Multi-sliced MR datasets with specified time intervals are used for input. The purpose is to provide a new composite "3TP Image" that provides a trained physician with information useful for diagnostic purposes.
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