U.S. Food and Drug Administration Grading System for Risk Evaluation of Software as Medical Device (15)
| Significance of AIMD | |||
|---|---|---|---|
| Patient condition | Non-CADe (e.g., measure, denoise, annotate; no interpretation) | CADe (e.g., identify abnormalities; dosimetry calculation) | CADx (e.g., guide diagnosis or treatment) |
| Not serious | I | I | II |
| Serious | I | II | III |
| Critical | II | III | IV |
I–IV represent lowest risk through highest risk.