VANTAGE ELAN

System, Nuclear Magnetic Resonance Imaging

TOSHIBA AMERICA MEDICAL SYSTEMS INC

The following data is part of a premarket notification filed by Toshiba America Medical Systems Inc with the FDA for Vantage Elan.

Pre-market Notification Details

Device IDK141472
510k NumberK141472
Device Name:VANTAGE ELAN
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS INC 2441 MICHELLE DRIVE Tustin,  CA  92780
ContactPaul Biggins
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 Received2014-06-03
Decision Date2014-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670101632 K141472 000
04987670101540 K141472 000
04987670101519 K141472 000

Trademark Results [VANTAGE ELAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VANTAGE ELAN
VANTAGE ELAN
79150061 4643194 Live/Registered
Canon Medical Systems Corporation
2014-04-18

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