FDA 510(k) Application Details - K082100

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K082100
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	ALLTECH MEDICAL SYSTEMS AMERICA, INC. 30825 AURORA ROAD SUITE 100 SOLON, OH 44139 US Other 510(k) Applications for this Company
Contact	JOHN DURAJ 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	07/25/2008
Decision Date	08/06/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review