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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 K940796
Device Name ACCESS
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Applicant Contact JAVAD SEYEDZADEH
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/22/1994
Decision Date 08/23/1994
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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