# K050862: 3TP Workspace - Pathway: 510(k) (Traditional) - Applicant: 3tp, LLC - Decided: Jul 25, 2005 after 111 days - Product code: LLZ (System, Image Processing, Radiological) - Device class: 2 - Regulation: 21 CFR 892.2050 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K913475 (1991). 7 ancestors in all. 10 later devices descend from it; 1 cites it directly. 0 of 18 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 6. - K011604: Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri, Ge Medical Systems, Inc. (2001) Summary page 6. - K971965: Philips Easyvision, Philips Medical Systems, Inc. (1998) Summary page 6. ## Most influential descendants - K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own - K092954: Cadstream Version 5 (2009), 8 descendants of its own - K170195: QuantX (2017), 4 descendants of its own - K210670: BU-CAD (2021), 3 descendants of its own - K231130: TumorSight Viz (2023), 2 descendants of its own ## Recalls of this device - Dec 9, 2008 · Not classified · Z-0653-2009: Software modules not approved for this indication. ## Indications for 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 algorithm. The Workspace supports the analysis and presentation of datasets 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. The POI and ROI curve functions provide contrast enhancement data for a specific pixel or region of interest within the MRI image series. Whereas the POI function measures signal intensity enhancement for a specific pixel, the ROI function averages the enhancement in signal intensity for a manually specified region (several pixels). In both cases, the Workspace presents a graph depicting the percent change in intensity through all time points. The Report Card function classifies, counts and calculates the percentage of pixels of a given color and intensity in a single or in multiple slices for any manually specified region of interest. The Report Card offers the user the ability to evaluate a subset of the data originally generated by the 3TP algorithm in a numbers based, non-image presentation format. The Report Card assists the user by providing number based data of the contrast kinetics of a specified region identified by the radiologist in order to further aid in his diagnosis. The Volume Calculation function allows the user to measure the volume of a region in multiple image slices specified by the radiologist. The “3TP Histogram” is used to simultaneously display measurements of two physiological parameters found from a full pharmacokinetic analysis of the dynamic behavior of voxels in a chosen ROI. Each bin in the histogram shows the total number of voxels from the designated ROI with corresponding Permeability (PERM) and Extracellular Volume Fraction (EVF). Two solid lines on the histogram plot show the Blue/Green and Green/Red separations of the map: That is, voxels in the bins of red section are colored red on 3TP-color maps based on full analysis. The Heterogeneity Analysis provides a standardized statistical analysis of the varying populations of color hue and color intensity within a specified region or volume of interest. This function assists the radiologist in determining the degree of heterogeneity or homogeneity of a user specified region in terms of the color-coded pixels that are contained within. If the Full Analysis was performed, Heterogeneity Analysis may be performed also for Permeability and EVF of voxels within specified ROI. The Workspace product serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the Workspace’s underlying workflow solution for lesion characterization and reporting. This inherent workflow regime integrates easily into the radiologist’s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. The 3-D Visualization tool provides colored Maximum Intensity Projections (MIP) or other 3D visualization tools that are specific to the 3TP image datasets. Source page: https://510kreport.com/device/K050862 Methodology: https://510kreport.com/methodology