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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 K925286
Device Name MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
Applicant
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Applicant Contact RON YOKOTA
Correspondent
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Correspondent Contact RON YOKOTA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/20/1992
Decision Date 10/07/1993
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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