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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 K964778
Device Name HI-STAR MRI IMAGING SYSTEM
Applicant
Health Images, Inc.
8601 Dunwoody Pl.
Suite 200
Atlanta,  GA  30350
Applicant Contact RICHARD E HALBACH
Correspondent
Health Images, Inc.
8601 Dunwoody Pl.
Suite 200
Atlanta,  GA  30350
Correspondent Contact RICHARD E HALBACH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/27/1996
Decision Date 02/24/1997
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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