Quantib Prostate
Quantib BVQuantib Prostate is advanced image post-processing software designed to assist trained medical professionals in analyzing prostate MRI scans. It provides tools for automatic and semi-automatic segmentation of the prostate, visualization of multiparametric MRI images, PI-RADS scoring, and lesion analysis. By combining multiple MRI sequences into a single view and supporting volume computations, it helps clinicians in the detailed interpretation of prostate imaging, potentially improving diagnostic accuracy.
Intended Use
Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
Technology
Quantib Prostate is an extension of the Quantib AI Node platform. It has modules for automatic prostate segmentation and multiparametric MRI image registration, as well as user interaction modules for editing segmentations, analyzing potential lesions, and viewing combined MRI images. It exports results for clinical use and processes standard DICOM prostate MRI sequences including T2-weighted, DWI, ADC, and DCE images.
Performance
Performance testing included bench testing of system functionality and characterization of prostate segmentation algorithm performance. Clinical testing showed that use of Quantib Prostate by trained professionals improved or equaled prostate segmentation quality compared to segmentation without the software. The device meets multiple recognized standards for medical device software and usability engineering.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/31/2020
1 month - 2
FDA Approval
10/11/2020
Other devices from Quantib BV
- Quantib Prostate2023 • 510K
- Quantib Prostate2022 • 510K
- Quantib ND2022 • 510K
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