FDA 510(k) Application Details - DEN200080

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200080
Device Name	Paige Prostate
Applicant	Paige.AI 11 Times Square 37th Floor New York City, NY 10036 US Other 510(k) Applications for this Company
Contact	Emre Gulturk Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2020
Decision Date	09/21/2021
Decision	DENG -
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review