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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K113052
Device Name INFINIX-CCI
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/13/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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