FDA 510(k) Application Details - K241273

Device Classification Name	More FDA Info for this Device
510(K) Number	K241273
Device Name	FullFocus
Applicant	Paige.AI, Inc 11 Times Sq Floor 37 New York, NY 10036 US Other 510(k) Applications for this Company
Contact	Mufaddal Jafferji Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2024
Decision Date	01/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review