DeviceClearance

Product code PNA— Neurology

EPIC ClearView System

Classification name
Evoked Photon Image Capture Device
Device class
Class 1
Regulation
21 CFR 882.1561
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PNA under 21 CFR 882.1561, via openFDA

Market context for product code PNA

FDA has cleared 1 device under product code PNA, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PNA

Recent clearances under product code PNA

Data sourced from openFDA. This site is unofficial and independent of the FDA.