FDA 510(k) Application Details - K191994

Device Classification Name	More FDA Info for this Device
510(K) Number	K191994
Device Name	ProFound AI Software V2.1
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	07/26/2019
Decision Date	10/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review