FDA 510(k) Application Details - K152038

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K152038
Device Name	System, X-Ray, Mammographic
Applicant	Women's Imaging Solutions Enterprises LLC 226 Wilson Drive Cresskill, NJ 07626 US Other 510(k) Applications for this Company
Contact	Nancy DeRobertis Other 510(k) Applications for this Contact
Regulation Number	892.1710   More FDA Info for this Regulation Number
Classification Product Code	IZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2015
Decision Date	12/22/2015
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