FDA 510(k) Application Details - K101898

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K101898
Device Name	System, Image Processing, Radiological
Applicant	R4 LLC 17999 FOLTZ PARKWAY STRONGSVILLE, OH 44149 US Other 510(k) Applications for this Company
Contact	CRISTIAN NEGRILA Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2010
Decision Date	09/15/2011
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