PNA · Evoked Photon Image Capture Device
Neurology · 21 CFR 882.1561 · Class 1
Overview
| Product Code | PNA |
|---|---|
| Device Name | Evoked Photon Image Capture Device |
| Regulation | 21 CFR 882.1561 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 882.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN150004 | EPIC ClearView System | Epic Research & Diagnostics, Inc. | Jul 15, 2016 | DENG |
Top Applicants
- Epic Research & Diagnostics, Inc. — 1 clearance
