510(k) Report

FDA applicant

Siemens Medical Solutions

Malvern, PA15 decisions2003–20254 recalls

FDA records 15 decisions for Siemens Medical Solutions (Malvern, PA) from 2003 to 2025: 15 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Siemens Medical Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 22008: 12010: 12022: 22023: 22024: 12025: 2
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2025

2007: 12024: 12025: 2
2007high 2 (2025) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solutions by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Siemens Medical Solutions’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological4decisions
  • KPRSystem, X-Ray, Stationary3decisions
  • OWBInterventional Fluoroscopic X-Ray System3decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision

Also: IZL (1), MOS (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 35 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 20075cite it
  • K043030Magnetom C! MR SystemSiemens Medical Solutions · 20044cite it
  • K101749Syngo Trued SoftwareSiemens Medical Solutions · 20104cite it
  • K061671Syngo Trued, Model VC10ASiemens Medical Solutions · 20062cite it
  • K060992Syngo US WorkplaceSiemens Medical Solutions · 20062cite it
  • K233543YSIO X.preeSiemens Medical Solutions · 20241cites it

What has FDA decided for it lately?

  • K250738YSIO X.preeSiemens Medical Solutions · 2025
  • K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions · 20252 recalls
  • K233543YSIO X.preeSiemens Medical Solutions · 2024
  • K233532MULTIX Impact ESiemens Medical Solutions · 2023
  • K231577MOBILETT ImpactSiemens Medical Solutions · 2023
  • K221281Multitom RaxSiemens Medical Solutions · 20221 recall
  • K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022
  • K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010

All 15 as Siemens Medical Solutions →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K250660Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number…Dec 29, 2025Class II
  • K250660Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number…Dec 29, 2025Class II
  • K221281Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern…Jul 2, 2024Class II
  • K060992syngo US Workplace Picture Archiving and Communication System, software version 2.0…Dec 6, 2007