FDA 510(k) Application Details - K182373

Device Classification Name	More FDA Info for this Device
510(K) Number	K182373
Device Name	PowerLook Tomo Detection V2 Software
Applicant	iCAD Inc. 98 Spitbrook Rd. Suite 100 Nashua, NH 03062 US Other 510(k) Applications for this Company
Contact	John DeLucia 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	08/31/2018
Decision Date	12/06/2018
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