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 categoryComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device IDB720BX360EASPECTS1210
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information