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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K132106
Device Name INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780 -2068
Applicant Contact PAUL BIGGINS
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780 -2068
Correspondent Contact PAUL BIGGINS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/08/2013
Decision Date 11/12/2013
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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