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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 K050132
Device Name NEURO II-S
Applicant
Innovative Magnetic Resonance Imaging Systems, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
Innovative Magnetic Resonance Imaging Systems, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/21/2005
Decision Date 02/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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