# K121517: Versavue Enterprise Suite

- Pathway: 510(k) (Special)
- Applicant: Icad, Inc.
- Decided: Jul 20, 2012 after 59 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 4 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K013306: Minime Nasal Mask, Model P/N 50220, Sleepnet Corporation (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K080672: Birthtrack, Barnev, Ltd. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K090724: OR-Light, Yperion Technology (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K111371: ON Call Chosen Blood Glucose Monitoring System, ACON Laboratories, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K192200: DynaCAD (2019), 6 descendants of its own
- K202501: Quantib Prostate (2020), 3 descendants of its own
- K221106: Quantib Prostate (2022), 1 descendant of its own
- K173744: ProFuse CAD (2018), 1 descendant of its own
- K233196: Medihub Prostate (2024), 0 descendants of its own

## Recalls of this device
- Jan 24, 2018 · Class II · Z-1289-2018: 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 dis

## Indications for use
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.

Source page: https://510kreport.com/device/K121517
Methodology: https://510kreport.com/methodology