FDA 510(k) Application Details - K111304

Device Classification Name	Device, Spot-Film   More FDA Info for this Device
510(K) Number	K111304
Device Name	Device, Spot-Film
Applicant	GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	NIDHI CHAUDHARY Other 510(k) Applications for this Contact
Regulation Number	892.1670   More FDA Info for this Regulation Number
Classification Product Code	IXL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2011
Decision Date	07/19/2011
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