Cardiology

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FDA-cleared AI medical device

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

FDA Submission Metadata

Submission number
DEN200030
Decision date
September 2021
FDA panel
Cardiovascular
Product code
QQI
Clinical task (npj)
quantification/feature localization
Data modality (npj)
Images

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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