Devices · Paige.AI

Paige Prostate

Paige.AI is listed for Paige Prostate (DEN200080). The FDA list gives September 21, 2021 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QPN as “Software Algorithm Device To Assist Users In Digital Pathology”: 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080

Official FDA database record

Date of final decision

September 21, 2021

Company on the FDA list

Paige.AI

Lead panel

Pathology

Primary product code

QPN

openFDA device name for the code

Software Algorithm Device To Assist Users In Digital Pathology

Device class

2

Regulation number

864.3750

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned