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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 K943021
Device Name MRT-150A
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Applicant Contact STEVE KAY
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Correspondent Contact STEVE KAY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/24/1994
Decision Date 10/14/1994
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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