DEVICE: Nevisense (07350094440071)
Device Identifier (DI) Information
Nevisense
511-0001
In Commercial Distribution
511-0001
Scibase AB
511-0001
In Commercial Distribution
511-0001
Scibase AB
Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score.
Electrical impedance is a measure of a material’s overall resistance to the flow of alternating electric currents of various frequencies.
The principle is that electrical impedance is different in normal versus abnormal tissue.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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42183 | Neoplasm 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).
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FDA Product Code
[?]Product Code | Product Code Name |
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ONV | Electrical Impedance Spectrometer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P150046 | 000 |
Sterilization
Storage and Handling
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Clinically Relevant Size
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Device Record Status
d276066d-54d5-4a51-a1fa-6f046b524b14
February 06, 2025
7
November 21, 2017
February 06, 2025
7
November 21, 2017
Alternative and Additional Identifiers Additional Identifiers
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined