- Registration Date 2023-07-20
- Hit 1158
This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS) and computer-aided detection/diagnosis (CAD) software fall under this category.
Division Digital Health Device Division
Written by Chungkeun Lee