FDA 510(k) Application Details - K203822

Device Classification Name	More FDA Info for this Device
510(K) Number	K203822
Device Name	ProFound AI Software V3.0
Applicant	iCAD Inc. 98 Spit Brook Rd. Suite 100 Nashua, NH 03062 US Other 510(k) Applications for this Company
Contact	Heather Reed Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2020
Decision Date	03/12/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review