Aquilion ONE Vision, V7.0

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, V7.0.

Pre-market Notification Details

Device IDK142465
510k NumberK142465
Device Name:Aquilion ONE Vision, V7.0
ClassificationSystem, X-ray, Tomography, Computed
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentOrlando Tadeo
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DRIVE Tustin,  CA  92780
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2015-03-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670100635 K142465 000

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