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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 K922470
Device Name IES, IMAGE ENHANCEMENT SYSTEM
Applicant
Open Mri, Inc.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Open Mri, Inc.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/26/1992
Decision Date 11/27/1992
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
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