510(k) DEN150004
DEN150004 is an FDA 510(k) premarket notification submitted by Epic Research & Diagnostics, Inc. for the device "EPIC ClearView System". The FDA issued a decision of De Novo Granted on July 15, 2016. The device falls under product code PNA (Evoked Photon Image Capture Device), a Class I device regulated under 21 CFR 882.1561.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 15, 2016
- Date Received
- January 13, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evoked Photon Image Capture Device
- Device Class
- Class I
- Regulation Number
- 882.1561
- Review Panel
- NE
- Submission Type
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.