FDA-cleared K191125
ADAS 3D
Galgo Medical S.L
Authorized purpose: ADAS 3D post-processes contrast cardiac MRI and CTA to visualize and quantify myocardial scar and export reviewed results to electrophysiology navigation systems; it is not intended to identify ablation targets.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Heart/Cardiovascular
- Decision
- 2020-01-15