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DynaCAD 3.5Recalls & reported problems

Icad, Inc. · The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software. The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis 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 viewer 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. DynaCAD 3 software 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 DynaCAD 3 software 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. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858012005786), received between Feb 26, 2018 and Feb 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Display/Image” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • No Display/Image1
  • Problem with Software Installation1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 26, 2018No Display/Image; Problem with Software Installation

    FOLLOWING THE UPDATE FROM V3.3 TO V3.5 OF THE DYNACAD SOFTWARE IT WAS NOTED THAT THE KTRANS MAP WAS NOT RENDERED CORRECTLY ON THE DYNACAD CLIENT. INVESTIGATION BY THE INVIVO FIELD TEAM DISCOVERED THAT THE KTRANS MAP WAS DISPLAYED CORRECTLY WHEN THE DYNACAD CLIENT WAS INSTALLED ON THE SERVER MACHINE, BUT NOT WHEN THE DYNACAD CLIENT WAS INSTALLED ON A REMOTE MACHINE.

    Patient problems: No Information

    MAUDE report 7298473 ↗

Other System, Image Processing, Radiological devices

All System, Image Processing, Radiological devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.