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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 K891543
Device Name MAGNAVIEW MOBILE MRI VERSION 110 FHM
Applicant
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Applicant Contact GERRY BUSS
Correspondent
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Correspondent Contact GERRY BUSS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/17/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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