INFX-8000C (INFINIX CC-I AND VC-I)

System, X-ray, Fluoroscopic, Image-intensified

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Infx-8000c (infinix Cc-i And Vc-i).

Pre-market Notification Details

Device IDK081621
510k NumberK081621
Device Name:INFX-8000C (INFINIX CC-I AND VC-I)
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactPaul Biggins
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-06-09
Decision Date2008-06-23
Summary:summary

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