510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150004Unknown

EPIC ClearView System

Epic Research & Diagnostics, Inc., Scottsdale AZ / Direct, Unknown
FDA source (opens on fda.gov)

DEN150004 is the FDA 510(k) clearance record for EPIC ClearView System, a class I device, cleared for Epic Research & Diagnostics, Inc. on under FDA product code PNA (Evoked Photon Image Capture Device). FDA's definition for product code PNA 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...". FDA records list one 510(k) clearance for Epic Research & Diagnostics, Inc. As of , FDA records show no recalls naming DEN150004.

Clearance record

Decision date
Received
(549 days to decision)
Product code
PNA Evoked Photon Image Capture Device
Regulation
21 CFR 882.1561
Device class
Class I
Review panel
Neurology
Applicant
Epic Research & Diagnostics, Inc. 7659 E Pinnacle Peak Rd. Suite 115, Scottsdale AZ
Third party review
No

Clearances, product code PNA

Trailing 12 months

FDA records hold no clearances under product code PNA in the trailing twelve months.

FDA records show no clearances under product code PNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260