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Regulatory
Chest XRay AI Solution - CXR Analyzer has received US FDA 510(k) Clearance
TUD SUV 13485 ISO Certified
Augmento - AI-powered Radiology Workflow Management Solution received US FDA 510(k) Clearance
Developed in accordance with IEC 62304 : 2006
(Medical device software — Software life cycle processes)
Systems and methods for selection of priority-wise artificially intelligent mechanisms per one or more characteristics
Application No.: 202321010405
ISO/IEC 27001 : 2013 certified
(Information Security Management)
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