QUIBIM Precision Prostate (qp-Prostate)
QUIBIM S.L.QUIBIM Precision Prostate (qp-Prostate) is software designed to assist trained professionals such as radiologists in viewing and analyzing prostate MRI scans. It offers advanced post-processing features to quantify diffusion and perfusion characteristics, helping clinicians better visualize prostate tissue and complete structured reports. This software enables improved image analysis and decision support without performing a direct diagnostic function.
Intended Use
qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. It allows viewing, processing and analysis of prostate MR images acquired through DICOM compliant devices. Patient management decisions should not be based solely on qp-Prostate, as it does not perform a diagnostic function but allows visualization and analysis of data.
Technology
qp-Prostate is a modular image processing and analysis software running on a client-server model accessed via web browser on standard computers. It supports DICOM Query/Retrieve from hospital PACS, processes MR prostate images using diffusion ADC and perfusion pharmacokinetics post-processing plug-ins to generate parametric maps (ADC, Ktrans, kep, ve). It includes a DICOM viewer with segmentation and reporting tools for prostate MR imaging.
Performance
Performance testing included bench validation using QIBA digital reference objects for diffusion and perfusion modules, and clinical testing on prostate MR datasets from multiple vendors and field strengths comparing against predicate device Olea Sphere v3.0. Tests validated image registration, motion correction, segmentation, smoothing, and arterial input function selection demonstrating safety, effectiveness, and substantial equivalence to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/7/2020
1 month - 2
FDA Approval
2/4/2021
Other devices from QUIBIM S.L.
- QP-Brain�2023 • 510K
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