MAGNETOM Lumina And MAGNETOM Vida Fit With Syngo MR XA50A

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 Lumina And Magnetom Vida Fit With Syngo Mr Xa50a.

Pre-market Notification Details

Device IDK220939
510k NumberK220939
Device Name:MAGNETOM Lumina And MAGNETOM Vida Fit With Syngo MR XA50A
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Malvern,  PA  19355
ContactAlina Goodman
CorrespondentAlina Goodman
Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Malvern,  PA  19355
Product CodeLNH  
Subsequent Product CodeLNI
Subsequent Product CodeMOS
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-04-29

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