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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 K926171
Device Name MRT-150A, QD SPINE COIL
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Applicant Contact RON YOKOTA
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Correspondent Contact RON YOKOTA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/08/1992
Decision Date 04/27/1993
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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