RSI-MRI+
CORTECHS LABS, INC. · Model 1.1 · UDI-DI 00860000004817
Description
RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical T2-weighted MR images. Some of the features of RSI-MRI+ include: • Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. • Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. • Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (AI) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Segmentation Series. • Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. • Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software. NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower inplane resolution for T2W images and thicker slices for the GE DW
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-22 | Merge Healthcare, Inc. | Software issue may cause measurements to be displayed inaccurately. |
| 2026-07-22 | FUJIFILM Healthcare Americas Corporation | Software issue may cause the ruler measurement to be inaccurate. |
| 2026-06-30 | Merge Healthcare, Inc. | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st |
| 2026-06-30 | Merge Healthcare, Inc. | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st |
| 2026-06-19 | Boston Scientific Corporation | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu |
| 2026-05-08 | GE Medical Systems SCS | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches |
| 2026-03-19 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re |
| 2026-03-05 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. |
| 2026-01-30 | GE Medical Systems, LLC | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w |
| 2026-01-30 | GE Medical Systems, LLC | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w |
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