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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 K970990
Device Name GYREX PRIMA 1TG 1.0T MRI SYSTEM
Applicant
Elscint Mr, Inc.
2555 Midpoint Dr.
Fort Collins,  CO  80525
Applicant Contact ELIZABETH F LOWDER
Correspondent
Elscint Mr, Inc.
2555 Midpoint Dr.
Fort Collins,  CO  80525
Correspondent Contact ELIZABETH F LOWDER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/18/1997
Decision Date 08/25/1997
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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