510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PNAClass I

Evoked Photon Image Capture Device

21 CFR 882.1561 / Neurology
FDA source (opens on fda.gov)

PNA is the FDA product code for Evoked Photon Image Capture Device, a class I device type, regulated under 21 CFR 882.1561. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PNA
Device name
Evoked Photon Image Capture Device
FDA 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.
Regulation
21 CFR 882.1561
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PNA

By decision year
1 clearance under product code PNA with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PNA by decision year
YearClearances
20161

Applicants with the most clearances

Product code PNA
Applicants holding the most 510(k) clearances under product code PNA
ApplicantClearances
Epic Research & Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code