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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 K893744
Device Name SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
Applicant
Shimadzu Medical Systems
C/O Biometric Research Inst
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Applicant Contact LYNNE SEEKAMP
Correspondent
Shimadzu Medical Systems
C/O Biometric Research Inst
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Correspondent Contact LYNNE SEEKAMP
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/18/1989
Decision Date 11/06/1989
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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