PNA

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Evoked Photon Image Capture Device

Device class

Class I (low risk)

Regulation

21 CFR 882.1561

Medical specialty

Neurology

FDA definition

The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin.

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