Paige Prostate

Software Algorithm Device To Assist Users In Digital Pathology


The following data is part of a De Novo classification by with the FDA for Paige Prostate.

Pre-market Notification Details

DeNovo IDDEN200080
Device Name:Paige Prostate
ClassificationSoftware Algorithm Device To Assist Users In Digital Pathology
Applicant Paige.AI 11 Times Square 37th Floor New York City,  NY  10036
ContactEmre Gulturk
Product CodeQPN  
CFR Regulation Number864.3750 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardPathology
Classification AdvisoryPathology
Date Received2020-12-31
Decision Date2021-09-21
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00860007599118 DEN200080 000

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