Vantage Titan 1.5T, V3.1, MRT-1510

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, V3.1, Mrt-1510.

Pre-market Notification Details

Device IDK150427
510k NumberK150427
Device Name:Vantage Titan 1.5T, V3.1, MRT-1510
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara,  JP 324-8550
ContactJanine Reyes
CorrespondentPaul Biggins
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 Received2015-02-19
Decision Date2015-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670101601 K150427 000

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