FDA 510(k) Application Details - K123417

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K123417
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.2, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.ZONE BEIJING 100176 CN Other 510(k) Applications for this Company
Contact	RUOQIAN LIU Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2012
Decision Date	01/17/2013
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