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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K141977

MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL · Siemens Medical Solutions USA, Inc. · decided 2014-11-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
MAGNETOM Aera10432914Siemens Healthcare GmbHLNH LNI MOS04056869006697
MAGNETOM Skyra10432915Siemens Healthcare GmbHLNH LNI MOS04056869006703
MAGNETOM Skyra10849580Siemens Healthcare GmbHLNH LNI MOS04056869006710