AQUILION PRIME, V5.00

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 Prime, V5.00.

Pre-market Notification Details

Device IDK130645
510k NumberK130645
Device Name:AQUILION PRIME, V5.00
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 Received2013-03-11
Decision Date2013-06-06
Summary:summary

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