Device Dossier

Information system software, application program, cardiology

Device Dossier for Information system software, application program, cardiology (Information system software, application program, cardiology, Class IIb,…

Intended purpose

The product is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, or Holter) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

TGA Public Summary