Magnetom Sola, Magnetom Altea And Magnetom Sola 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 Sola, Magnetom Altea And Magnetom Sola Fit.

Pre-market Notification Details

Device IDK192496
510k NumberK192496
Device Name:Magnetom Sola, Magnetom Altea And Magnetom Sola Fit
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, Mail Code 65-IA Malvern,  PA  19355
ContactCordell L Fields
CorrespondentCordell L Fields
Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, Mail Code 65-IA 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 Received2019-09-11
Decision Date2020-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869245195 K192496 000
04056869230719 K192496 000

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