FDA 510(k) Application Details - K151924

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K151924
Device Name	System, X-Ray, Stationary
Applicant	QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM 2002-B ORVILLE DRIVE NORTH RONKONKOMA, NY 11779 US Other 510(k) Applications for this Company
Contact	MARK CAMIRAND Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2015
Decision Date	08/07/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review