MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit

System, Nuclear Magnetic Resonance Imaging

Siemens Medical Solutions USA Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Vida, Magnetom Lumina, Magnetom Vida Fit.

Pre-market Notification Details

Device IDK192924
510k NumberK192924
Device Name:MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, MailCode 65-1A Malvern,  PA  19355
ContactAndrew Turner
CorrespondentAndrew Turner
Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, MailCode 65-1A Malvern,  PA  19355
Product CodeLNH  
Subsequent Product CodeLNI
Subsequent Product CodeMOS
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-16
Decision Date2020-03-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869245188 K192924 000

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