AQUILION ONE VISION, V6.0

System, X-ray, Tomography, Computed

TOSHIBA MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aquilion One Vision, V6.0.

Pre-market Notification Details

Device IDK132222
510k NumberK132222
Device Name:AQUILION ONE VISION, V6.0
ClassificationSystem, X-ray, Tomography, Computed
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
ContactPaul Biggins
CorrespondentPaul Biggins
TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-17
Decision Date2013-11-07
Summary:summary

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