Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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) K201130 ACUSON Juniper Diagnostic Ultrasound SystemIYN2020-05-26 View
510(k) K201062 syngo Ultrasound Apps Suite (sUSAS)LLZ2020-05-18 View
510(k) K201034 Syngo.CT CaScoringJAK2020-05-14 View
510(k) K200213 Biograph mMR with syngo MR E11P-AP01 system softwareOUO2020-05-11 View
510(k) K200585 Acuson SC2000 Diagnostic Ultrasound SystemIYN2020-04-22 View
510(k) K193326 ARTIS IconoOWB2020-04-16 View
510(k) K200707 ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-04-15 View
510(k) K200644 ACUSON Freestyle Diagnostic Ultrasound SystemIYN2020-04-10 View
510(k) K200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOJAK2020-04-01 View
510(k) K193089 MULTIX ImpactKPR2020-03-20 View
510(k) K200474 Symbia 6.7KPS2020-03-20 View
510(k) K193267 Al-Rad Companion (Musculoskeletal)JAK2020-03-16 View
510(k) K192924 MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitLNH2020-03-11 View
510(k) K192496 Magnetom Sola, Magnetom Altea and Magnetom Sola FitLNH2020-02-28 View
510(k) K193248 Biograph Vision, Biograph mCT Family of PET/CTsKPS2020-02-14 View
510(k) K192462 syngo.MR ApplicationsLLZ2020-01-31 View
510(k) K193257 ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-01-31 View
510(k) K192763 syngo.CT CaScoringJAK2019-12-17 View
510(k) K192061 SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GOJAK2019-11-21 View
510(k) K191891 SOMATOM X.citeJAK2019-11-06 View

Page 8 of 13

↑