meddevicedb.com FDA Device Reference

Paige Prostate

DEN200080 Class II Direct
Decision Date
2021-09-21
Sponsor / Applicant
Paige.Ai

Technical Specification

510(k) Submission ID DEN200080
Product Code QPN
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 864.3750
Decision Date 2021-09-21
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Paige Prostate received FDA 510(k) clearance under submission number DEN200080, sponsored by Paige.Ai. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2021-09-21.

Classification & Regulation

This clearance is catalogued under FDA product code QPN and 21 CFR 864.3750, within the Pathology review panel as a Class II device.