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Critical Care Suite
Critical Care Suite 2.1, Designated Medical Device
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 categoryAutomated Radiological Image Processing Software, Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Device ID00195278789365
Catalog number5833126
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information