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Cognet AI
The CogNet AI-MT+ is a software as a Medical Device for screening Mammograms in DBT format. This software is a triage device that allows the result to be prioritized for viewing by a qualified radiologist.
Details
Device typeX-ray image interpretive software: An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
FDA categoryRadiological Computer-Assisted Prioritization Software For Lesions
Device ID00860007434716
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information