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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 K900285
Device Name MRT 50A FLEXIBLE BODY COIL
Applicant
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Applicant Contact JAVAD SEYEDZADEH
Correspondent
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/22/1990
Decision Date 03/09/1990
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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