Information system software, application program, cardiology

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

GE Healthcare Australia Pty Ltd

Klasse:

Class IIa

Produsert av:

GE Medical Systems Information Technologies Inc 9990 Innovation Drive, Wauwatosa, WI, 53226 United States Of America

Terapeutisk område:

44098 - Information system software, application program, cardiology

Indikasjoner:

EK12 v2 analyzes 10 or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements. EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnostic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG. EK12 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or physician?s office.

Autorisasjon status:

A

Autorisasjon dato:

2023-08-24