510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220066Unknown

BrainSee

Darmiyan, Inc., Berkeley CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220066 is the FDA 510(k) clearance record for BrainSee, a class II device, cleared for Darmiyan, Inc. on under FDA product code QWT (Prognostic Assessment Software Of Mild Cognitive Impairment). FDA's definition for product code QWT reads: "Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output...". FDA records list one 510(k) clearance for Darmiyan, Inc. As of , FDA records show no recalls naming DEN220066.

Clearance record

Decision date
Received
(469 days to decision)
Product code
QWT Prognostic Assessment Software Of Mild Cognitive Impairment
Regulation
21 CFR 882.1454
Device class
Class II
Review panel
Neurology
Applicant
Darmiyan, Inc. 1425 Berkeley Way, Berkeley CA
Third party review
No

Clearances, product code QWT

Trailing 12 months

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

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