FDA 510(k) Application Details - K240417

Device Classification Name	More FDA Info for this Device
510(K) Number	K240417
Device Name	ProFound Detection (V4.0)
Applicant	iCAD, Inc. 98 Spit Brook Road, Suite 100 Nashua, NH 03062 US Other 510(k) Applications for this Company
Contact	Spence Hartwell 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	02/13/2024
Decision Date	11/08/2024
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