FDA product code PNA: Evoked Photon Image Capture Device
PNA is the FDA product code for evoked photon image capture device. It is a Class I device, regulated under 21 CFR 882.1561 and reviewed by the Neurology panel. Devices under PNA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Evoked Photon Image Capture Device |
| Device class | Class I |
| Regulation | 21 CFR 882.1561 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for PNA devices
openFDA lists no recalls for product code PNA.
Frequently asked questions
What is FDA product code PNA?
PNA is the FDA product code for evoked photon image capture device. It is a Class I device, regulated under 21 CFR 882.1561 and reviewed by the Neurology panel.
What device class is PNA?
Class I, regulation 21 CFR 882.1561. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PNA
- Run a recall and safety report across every PNA manufacturer
- Watch product code PNA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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