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3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Quibim S.L.
Authorized purpose: QP-Prostate CAD detects and marks suspected prostate lesions for clinically significant prostate cancer on bi-parametric T2-weighted and diffusion-weighted prostate MRI, returning moderate/high suspicion overlays in DICOM to third-party workstations/PACS for concurrent physician review; patient management must not rely on it alone.
Quibim S.L.
Authorized purpose: Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and older, as a support tool for properly trained clinicians assessing structural MRIs; patient-management decisions must not rely solely on the device results.
QUIBIM S.L.
Authorized purpose: Views, processes, and analyzes prostate MR images for trained professionals; it is not diagnostic and decisions should not rely solely on its results.