510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200080Unknown

Paige Prostate

Paige.ai, Inc, New York NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN200080 is the FDA 510(k) clearance record for Paige Prostate, a class II device, cleared for Paige.Ai on under FDA product code QPN (Software Algorithm Device To Assist Users In Digital Pathology). FDA's definition for product code QPN reads: "A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user...". FDA records list 3 510(k) clearances for Paige.Ai, from to . As of , FDA records show no recalls naming DEN200080.

Clearance record

Decision date
Received
(264 days to decision)
Product code
QPN Software Algorithm Device To Assist Users In Digital Pathology
Regulation
21 CFR 864.3750
Device class
Class II
Review panel
Pathology
Applicant
Paige.Ai 11 Times Sq. 37th Floor, New York NY
Third party review
No

Clearances, product code QPN

Trailing 12 months

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

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