Device Dossier
Cardiac electrophysiology application software
Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIb, sponsor Elevate Medtech).…
- GMDN category: Cardiac electrophysiology application software
Intended purpose
Software that uses deep learning algorithms to analyze ECG images or waveform data to assist in the diagnosis of arrhythmias and provide risk scores for cardiac dysfunction, thereby assisting physicians in their diagnostic decision-making.