510(k) · Cleared
Recalled · Class II · 2018Versavue Enterprise Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icad, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 20, 2012 after a 59-day review. The summary cites 4 numbers, none of which could be confirmed as its predicate (see the table below). 9 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 4
9 later devices descend from it, 2 citing it directly.
- This deviceK121517 Versavue Enterprise SuiteIcad, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK192200 DynaCADInvivo Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK202501 Quantib ProstateQuantib B.V. · 2020
- Descendant · 3 generations on · 1 of its ownK221106 Quantib ProstateQuantib B.V. · 2022
- Descendant · cites it directly · 1 of its ownK173744 ProFuse CADEigen · 2018
- Descendant · 3 generations on · 0 of its ownK233196 Medihub ProstateJLK, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192200DynaCADInvivo Corporation · 2019 · cites it directly6descendants
- K202501Quantib ProstateQuantib B.V. · 2020 · 2 generations on3descendants
- K221106Quantib ProstateQuantib B.V. · 2022 · 3 generations on1descendant
- K173744ProFuse CADEigen · 2018 · cites it directly1descendant
- K233196Medihub ProstateJLK, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121517 | Versavue Enterprise Suite | Icad, Inc. | 2012 | — |
| +1 | K192200 | DynaCAD | Invivo Corporation | 2019 | — |
| +2 | K202501 | Quantib Prostate | Quantib B.V. | 2020 | — |
| +3 | K221106 | Quantib Prostate | Quantib B.V. | 2022 | — |
| +1 | K173744 | ProFuse CAD | Eigen | 2018 | — |
| +3 | K233196 | Medihub Prostate | JLK, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K013306 | FDA’s K013306 is Minime Nasal Mask, Model P/N 50220 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| Kept off the family tree | K080672 | FDA’s K080672 is Birthtrack Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| Kept off the family tree | K090724 | FDA’s K090724 is OR-Light Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| Kept off the family tree | K111371 | FDA’s K111371 is ON Call Chosen Blood Glucose Monitoring System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2018 | Class II | Z-1289-2018 | Other | Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192200 (Invivo Corporation, 2019) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 VersaVueTM Enterprise Suite consists of the MR Analysis Server software and the VersaVue Enterprise Workstation software. The MR Analysis Server software, which includes the SpectraLook®, VividLook® and OmniLook® modules is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and…
Read the full statement (259 words)
The VersaVueTM Enterprise Suite consists of the MR Analysis Server software and the VersaVue Enterprise Workstation software.
The MR Analysis Server software, which includes the SpectraLook®, VividLook® and OmniLook® modules is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The VersaVue Enterprise Workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
The VersaVue Enterprise Suite 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 Suite's underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121517: Versavue Enterprise Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121517
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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