Transparency Registry · product code QVD
Quantitative imaging (adaptive) AI: all 1 FDA clearances
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan. Machine-learning quantitative imaging software cleared with a predetermined change-control plan — the FDA pathway that lets models update within pre-agreed bounds. This list is generated from openFDA public records and refreshes automatically every week — bookmark it and it stays current.
| Device | Applicant | Decision date |
|---|---|---|
| Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc. | 2023-02-24 |
Facts only, sourced per entry. Listing is not evaluation. Full methodology on the registry index. Evaluating this category? The due-diligence checklist and free instruments are where buyers start.