510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130033Unknown

Cognivue

Cerebral Assessment Systems, Inc., Pittsford NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN130033 is the FDA 510(k) clearance record for COGNIVUE, a class II device, cleared for Cerebral Assessment Systems, Inc. on under FDA product code PKQ (Computerized Cognitive Assessment Aid). FDA's definition for product code PKQ reads: "The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose...". FDA records list one 510(k) clearance for Cerebral Assessment Systems, Inc. As of , FDA records show no recalls naming DEN130033.

Clearance record

Decision date
Received
(723 days to decision)
Product code
PKQ Computerized Cognitive Assessment Aid
Regulation
21 CFR 882.1470
Device class
Class II
Review panel
Neurology
Applicant
Cerebral Assessment Systems, Inc. 10 Pond View Dr., Pittsford NY
Third party review
No

Clearances, product code PKQ

Trailing 12 months

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

FDA records show no clearances under product code PKQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PKQ, 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