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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 K944724
Device Name HEALTH IMAGE INC. HI STAR
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 Received09/25/1994
Decision Date 08/30/1995
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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