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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 K905442
Device Name MRT35-SP
Applicant
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Applicant Contact BEN KHOSRAVI
Correspondent
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Correspondent Contact BEN KHOSRAVI
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/25/1990
Decision Date 12/21/1990
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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