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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 K992992
Device Name AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact DIANA THORSON
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Correspondent Contact DIANA THORSON
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/07/1999
Decision Date 12/03/1999
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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