Vantage Titan 1.5T, MRT-1510, V3.6 Software

System, Nuclear Magnetic Resonance Imaging

TOSHIBA MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Titan 1.5t, Mrt-1510, V3.6 Software.

Pre-market Notification Details

Device IDK160632
510k NumberK160632
Device Name:Vantage Titan 1.5T, MRT-1510, V3.6 Software
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentJanine Faith Reyes
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DRIVE Tustin,  CA  92780
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-07
Decision Date2016-08-23
Summary:summary

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