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510(k) DEN200080

Paige Prostate by Paige.Ai — Product Code QPN

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 21, 2021
Date Received
December 31, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software Algorithm Device To Assist Users In Digital Pathology
Device Class
Class II
Regulation Number
864.3750
Review Panel
PA
Submission Type

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 about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.

Other clearances by Paige.Ai

  • K241273 — FullFocus (January 9, 2025)
  • K201005 — FullFocus (July 15, 2020)

Other clearances for product code QPN

  • K241232 — Galen™ Second Read™ (January 24, 2025)