Information system software, application program, cardiology

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné s:

GE Healthcare Australia Pty Ltd

Třída:

Class IIa

Výrobce:

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

Terapeutické oblasti:

44098 - Information system software, application program, cardiology

Terapeutické indikace:

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.

Stav Autorizace:

A

Datum autorizace:

2023-08-24