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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