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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 K944228
Device Name HEALTH IMAGES, INC. HI-STANDARD
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 Received08/31/1994
Decision Date 07/20/1995
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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