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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 K081624
Device Name INFX-8000F (INFINIX CSI AND INFINIX DPI)
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN,  CA  92781 -2068
Applicant Contact PAUL BIGGINS
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/10/2008
Decision Date 06/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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