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Siemens Medical Solutions USA, Inc.

FDA 510(k) & PMA Approved Devices — 252 products

Total Devices252
Categories18
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
510(k) K163284 syngo. CT Neuro PerfusionJAK2017-03-01 View
510(k) K163234 Biograph mMR with syngo MR E11P system softwareOUO2017-02-28 View
510(k) K163478 AcuNav Volume ICE CatheterOBJ2017-02-09 View
510(k) K163341 syngo.CT Extended FunctionalityJAK2017-02-09 View
510(k) K163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologyLLZ2017-02-06 View
510(k) K163211 MAGNETOM Sempra with syngo MR E11SLNH2017-01-27 View
510(k) K163312 MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareLNH2017-01-27 View
510(k) K163252 Mammomat Fusion with Stereotactic BiopsyMUE2017-01-10 View
510(k) K162483 Symbia Intevo BoldKPS2017-01-09 View
510(k) K163396 ACUSON P500 Ultrasound SystemIYN2017-01-04 View
510(k) K163421 syngo.via MI WorkflowsLLZ2017-01-03 View
510(k) K162302 Somatom Confidence ® RT ProJAK2016-12-16 View
510(k) K162971 Multix Fusion MaxKPR2016-11-22 View
510(k) K161795 MAGNETOM ESSENZALNH2016-11-18 View
510(k) K162541 syngo Application SoftwareLLZ2016-11-16 View
510(k) K162736 Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTKPS2016-10-25 View
510(k) K162370 syngo.via RT Image SuiteMUJ2016-10-25 View
510(k) K162339 SceniumLLZ2016-09-21 View
510(k) K162337 Symbia 6.5KPS2016-09-08 View
510(k) K161196 SOMATOM DriveJAK2016-08-24 View

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