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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K002522
Device Name OPART, MODEL MRT-600
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Applicant Contact BRUCE CLARK
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Correspondent Contact BRUCE CLARK
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/15/2000
Decision Date 10/25/2000
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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