Paige Prostate

Software Algorithm Device To Assist Users In Digital Pathology

Paige.AI

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

Pre-market Notification Details

• DeNovo ID: DEN200080
• Device Name: Paige Prostate
• Classification: Software Algorithm Device To Assist Users In Digital Pathology
• Applicant: Paige.AI 11 Times Square 37th Floor New York City, NY 10036
• Contact: Emre Gulturk
• Product Code: QPN
• CFR Regulation Number: 864.3750 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Pathology
• Classification Advisory: Pathology
• Type: Direct
• Date Received: 2020-12-31
• Decision Date: 2021-09-21
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860007599118	DEN200080	000