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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K983514
Device Name POSITRON OPTION, MODEL NSCO-050A
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact DONNELLE KRAJEWSKI
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Correspondent Contact DONNELLE KRAJEWSKI
Regulation Number892.1200
Classification Product Code
KPS  
Date Received10/07/1998
Decision Date 12/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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