FDA 510(k) Application Details - K113248

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K113248
Device Name	System, X-Ray, Stationary
Applicant	KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER NEW YORK, NY 10017 US Other 510(k) Applications for this Company
Contact	RUSSELL MUNVES 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	11/03/2011
Decision Date	01/17/2012
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