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FDA-cleared K231324

DASI Dimensions (V1.0)

DASI Simulations

Authorized purpose: Provide predefined cardiovascular images and measurements to support pre-procedural planning for patients with aortic stenosis being considered for TAVR; cardiologists and radiologists must interpret and validate the report and make all treatment decisions.

Modality
CT/CTA
Anatomy
Cardiovascular structures (aortic root, aortic valve, sinus of Valsalva, sinotubular junction, and ascending aorta)
Decision
2024-01-08