AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2

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 Version 4.6 W/dual Energy Scan System, Model Tsx-301a/2.

Pre-market Notification Details

Device IDK093891
510k NumberK093891
Device Name:AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
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)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-18
Decision Date2010-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670100611 K093891 000

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