FDA 510(k) Application Details - K122026

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K122026
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	PRISM CLINICAL IMAGING, INC. 890 Elm Grove Rd., Suite 215 Elm Grove, WI 53122 US Other 510(k) Applications for this Company
Contact	JAMES L REUSS 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	07/11/2012
Decision Date	09/21/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review