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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 K002531
Device Name EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
Applicant
Toshiba America Mri, Inc.
280 Utah Ave.
South San Francisco,  CA  94080 -6883
Applicant Contact KEN NEHMER
Correspondent
Toshiba America Mri, Inc.
280 Utah Ave.
South San Francisco,  CA  94080 -6883
Correspondent Contact KEN NEHMER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/16/2000
Decision Date 10/26/2000
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
Recalls CDRH Recalls
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