Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Siemens and its 58 subsidiaries with 3,189 510(k) clearances, 1,539 device recalls, 101 AI-enabled devices, 3 drug applications and 1 drug recall. The most recent is a 510(k) clearance dated Sep 25, 2026: syngo.CT Brain Quantification.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Siemens and its 58 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 25, 2026 | syngo.CT Brain QuantificationK260055 · QIH | 510(k) clearances |
| Sep 10, 2026 | ACUNAV Luxera 4D ICE CatheterK261696 · OBJ | 510(k) clearances |
| Aug 31, 2026 | MULTIX Impact; MULTIX Impact CK260488 · KPR | 510(k) clearances |
| Aug 10, 2026 | Atellica IM CA 19-9 IIK253528 · NIG | 510(k) clearances |
| Aug 3, 2026 | Halcyon, Ethos Radiotherapy System (5.0)K261856 · IYE | 510(k) clearances |
| Jul 24, 2026 | Atellica CH Acetaminophen 2 (ACTM)K261364 · LDP | 510(k) clearances |
| Jul 10, 2026 | AI Contouring (VA10A)K261306 · QKB | 510(k) clearances |
| Jul 8, 2026 | Virtual Cone (1.0)K260750 · MUJ | 510(k) clearances |
| Jun 25, 2026 | syngo.CT Coronary CockpitK253786 · Radiology | AI-enabled devices |
| Jun 16, 2026 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemK260844 · Radiology | AI-enabled devices |
| Jun 15, 2026 | LungMapsK253690 · Radiology | AI-enabled devices |
| Apr 29, 2026 | syngo Application SoftwareK254184 · Radiology | AI-enabled devices |
| Apr 10, 2026 | syngo Dynamics (VA41F)K253689 · Radiology | AI-enabled devices |
| Apr 10, 2026 | AI-Rad Companion Organs RTK252548 · Radiology | AI-enabled devices |
| Mar 20, 2026 | SOMATOM X.cite; SOMATOM X.ceedK253574 · Radiology | AI-enabled devices |
| Mar 18, 2026 | syngo.via RT Image Suite VC10K252304 · Radiology | AI-enabled devices |
| May 9, 2014 | ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lClass II · Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could f | Device recalls |
| Feb 22, 2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville,Class II · cGMP Deviation | Drug recalls |
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
