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Siemens Medical Solutions USA

Medical device makerAI in United StatesAI, part of Siemens. FDA records under 23 spellings of its name, each linked to the record.

  • 510(k) clearances: 848
  • Device recalls: 796
  • AI-enabled devices: 75

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Sep 25, 2026syngo.CT Brain QuantificationK260055 · QIH510(k) clearances
Sep 10, 2026ACUNAV Luxera 4D ICE CatheterK261696 · OBJ510(k) clearances
Aug 31, 2026MULTIX Impact; MULTIX Impact CK260488 · KPR510(k) clearances
Jun 25, 2026syngo.CT Coronary CockpitK253786 · QIH510(k) clearances
Jun 25, 2026syngo.CT Coronary CockpitK253786 · RadiologyAI-enabled devices
Jun 18, 2026MAMMOMAT B.brilliant (11372950)K253678 · MUE510(k) clearances
Jun 16, 2026ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemK260844 · IYN510(k) clearances
Jun 16, 2026ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemK260844 · RadiologyAI-enabled devices
May 21, 2026Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilyK261315 · KPS510(k) clearances
Apr 29, 2026syngo Application SoftwareK254184 · QIH510(k) clearances
Apr 29, 2026syngo Application SoftwareK254184 · RadiologyAI-enabled devices
Mar 20, 2026SOMATOM X.cite; SOMATOM X.ceedK253574 · RadiologyAI-enabled devices
Feb 10, 2026MI View&GOK254016 · RadiologyAI-enabled devices
Aug 20, 2025ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemK251481 · RadiologyAI-enabled devices
Jul 31, 2025YSIO X.preeK250738 · RadiologyAI-enabled devices
Jul 14, 2025LUMINOS Q.namix T; LUMINOS Q.namix RK250660 · RadiologyAI-enabled devices
Jul 13, 2012syngo Dynamics Version 9.5Class II · If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for anDevice recalls

Canada and Imports

Matched by company name
Active Health Canada device licences
49, as of Nov 10, 2026
FDA import refusals since 2024
2 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Siemens Medical Solutions USA, Inc.Siemens Medical Solutions USA, IncSiemens Medical Solutions USA Inc.Siemens AG Medical SolutionsSiemens Medical Solutions USA, IncSiemens Medical SolutionsSiemens Medical Solutions U.S.A.SIEMENS MEDICAL SOLUTIONS USA, INC.Siemens Medical Solutions, USA, Inc.SIEMENS MEDICAL SOLUTIONS USA, INCSiemens Medical Solutions USA, INCSiemens Medical Solutions, USA, IncSiemens Medical Solutions, IncSiemens Medical Solution USA, Inc.Siemens Medical Solution, Inc. USASiemens Medical Soultions USA, Inc.
Wikidata
Q472451

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.