CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Description
The CARTO 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter’s location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
Detailed example
The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
AI / analytics pattern
Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Supports identification of and viewing heart activity patterns.
Controls / human review
ATO: Not reported; PIA: Not published