PNA — Evoked Photon Image Capture Device Class I
FDA product code PNA covers "Evoked Photon Image Capture Device", a Class I medical device regulated under 21 CFR 882.1561. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PNA
- Device Class
- Class I
- Regulation Number
- 882.1561
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN150004 | epic research and diagnostics | EPIC ClearView System | July 15, 2016 |