FDA 510(k) Application Details - K122174

Device Classification Name	Cradle, Patient, Radiologic   More FDA Info for this Device
510(K) Number	K122174
Device Name	Cradle, Patient, Radiologic
Applicant	GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR AURORA, OH 44202-9273 US Other 510(k) Applications for this Company
Contact	MICHELLE HUETTNER Other 510(k) Applications for this Contact
Regulation Number	892.1830   More FDA Info for this Regulation Number
Classification Product Code	KXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2012
Decision Date	11/16/2012
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