Nevisense - Electrical impedance scanner

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

E3 Health Pty Ltd

Clasă:

Class IIa

Produs de:

SciBase AB Landsvagen 39, Sundbyberg, Sweden, 172 63 Sweden

Zonă Terapeutică:

42183 - Electrical impedance scanner

Indicații terapeutice:

Nevisense EIS functionality is intended for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma. Nevisense is designed to be used to obtain additional information prior to decision about most appropriate action for the patient. Nevisense should not be used to confirm a clinical diagnosis of melanoma. Nevisense EIS functionality is only for use by medical professional trained in the clinical diagnosis of skin cancer. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to decision about most appropriate action. Nevisense View functionality is intended for documentation and not for diagnostic purposes. The system is also intended to use for research purposes in general measurement of electrical impedance of the skin. The research measurements could be made with non invasive as well with micro invasive (spike) electrodes.

Statutul autorizaţiei:

A

Data de autorizare:

2020-04-03