FDA 510(k) Application Details - K063513

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K063513
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK TWINSBURG, OH 44080 US Other 510(k) Applications for this Company
Contact	DOUGLAS J 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	11/21/2006
Decision Date	12/12/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review