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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 K983902
Device Name FIELD EFFECTS MRI SYSTEM
Applicant
Intermagnetics General Corp.
450 Old Niskayuna Rd.
P.O. Box 461
Latham,  NY  12110
Applicant Contact IAN L PYKETT
Correspondent
Intermagnetics General Corp.
450 Old Niskayuna Rd.
P.O. Box 461
Latham,  NY  12110
Correspondent Contact IAN L PYKETT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/03/1998
Decision Date 01/07/1999
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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