MAGNETOM Free.Max, MAGNETOM Free.Star

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 Free.max, Magnetom Free.star.

Pre-market Notification Details

Device IDK220575
510k NumberK220575
Device Name:MAGNETOM Free.Max, MAGNETOM Free.Star
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern,  PA  19355
ContactAlina Goodman
CorrespondentAlina Goodman
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern,  PA  19355
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869281926 K220575 000
04056869281773 K220575 000
04056869281766 K220575 000
04056869281759 K220575 000

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