FDA 510(k) Application Details - K211506

Device Classification Name	More FDA Info for this Device
510(K) Number	K211506
Device Name	PowerLook Density Assessment V4.0
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	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2021
Decision Date	07/12/2021
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