PNA

Evoked Photon Image Capture Device

Product code

PNA

Device name

Evoked Photon Image Capture Device

Device class

Class 1

21 CFR

21 CFR 882.1561

Medical specialty

Neurology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).