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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 K911746
Device Name H.I.STANDARD CALIBRE UPGRADE
Applicant
Health Images, Inc.
8601 Dunwoody Pl.
Suite 200
Atlanta,  GA  30350
Applicant Contact BRUCE STEVENSON
Correspondent
Health Images, Inc.
8601 Dunwoody Pl.
Suite 200
Atlanta,  GA  30350
Correspondent Contact BRUCE STEVENSON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/18/1991
Decision Date 08/16/1991
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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