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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K101813
Device Name IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
Applicant
Imris, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
Imris, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
IZI  
Date Received06/29/2010
Decision Date 10/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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