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Probe unit
Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe.
Details
Device typeNeoplasm electrical impedance spectrometer: An electrically-powered instrument intended to measure/map the differences in capacitance and resistance between neoplastic and surrounding normal tissue, using electrical impedance (bioimpedance) spectroscopy (EIS/BIS). It provides real-time, noninvasive, radiation-free measurement and/or imaging of local distributions of tissue electrical impedance by applying and detecting a low-voltage electrical signal through the skin, via cutaneous electrodes, and displaying the results on a built-in or external screen (e.g., monitor, tablet). It is used for the detection of neoplastic skin and breast cancer, typically in combination with other methodologies (e.g., mammography, visual examination).
FDA categoryElectrical Impedance Spectrometer
Device ID07350094440088
Catalog number512-0003
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information