MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

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 Sola, Magnetom Lumina, Magnetom Altea.

Pre-market Notification Details

Device IDK203443
510k NumberK203443
Device Name:MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-03-31

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