510(k) · Cleared
Recalled · 20083TP Workspace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3tp, LLC · LLZ System, Image Processing, Radiological
Cleared on Jul 25, 2005 as substantially equivalent to K960265 (GE Medical Systems, 1996) and 2 other predicates after a 111-day review. Its family tree reaches back 3 generations to 1991. 10 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K913475 (1991). 7 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 2 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 1 generation backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- This deviceK050862 3TP Workspace3tp, LLC · 2005
- Descendant · cites it directly · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK231130 TumorSight VizSimBioSys, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · cites it directly9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 2 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 2 generations on4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 3 generations on3descendants
- K231130TumorSight VizSimBioSys, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −2 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −1 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K050862 | 3TP Workspace | 3tp, LLC | 2005 | — |
| +1 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +2 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +2 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +3 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| +3 | K231130 | TumorSight Viz | SimBioSys, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960265 | Advantage Windows with Functool OptionSummary page 6…ices GE Advantage Windows GE Prostate Spectroscopy Philips EasyVision With Functool Option and Imaging Exam (PROSE) (Quantitative Analysis (K960265) (K011604) Option) (K971965) GE Medical Systems GE Medical Systems P… | 1996 |
| * | K011604 | Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MriSummary page 6…dows GE Prostate Spectroscopy Philips EasyVision With Functool Option and Imaging Exam (PROSE) (Quantitative Analysis (K960265) (K011604) Option) (K971965) GE Medical Systems GE Medical Systems Philips Medical Systems… | 2001 |
| * | K971965 | Philips EasyvisionSummary page 6…hilips EasyVision With Functool Option and Imaging Exam (PROSE) (Quantitative Analysis (K960265) (K011604) Option) (K971965) GE Medical Systems GE Medical Systems Philips Medical Systems 300 N. Grandview Blvd. 300 N. Grandview Blv… | 1998 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081556 | Cadstream, Version 5.0 | 2009 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2008 | Not classified | Z-0653-2009 | PMA | Software modules not approved for this indication. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K081556 (Confirma, Inc., 2009) has gone furthest, with 9 descendants of its own.
- 12 other devices also cite its predicate K960265.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (541 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050862: 3TP Workspace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050862
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026