FDA 510(k) Application Details - K081745

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K081745
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK TWINSBURG, OH 44087 US Other 510(k) Applications for this Company
Contact	DOUG THISTLEWAITE Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2008
Decision Date	08/12/2008
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