DUAL ENERGY SYSTEM PACKAGE

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 Dual Energy System Package.

Pre-market Notification Details

Device IDK132813
510k NumberK132813
Device Name:DUAL ENERGY SYSTEM PACKAGE
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 Received2013-09-09
Decision Date2014-02-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.