510(k) Report

FDA applicant

Siemens Medical Solution USA, Inc.

Malvern, PA11 decisions2004–202286 recalls

FDA records 11 decisions for Siemens Medical Solution USA, Inc. (Malvern, PA) from 2004 to 2022: 11 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 3 of them its own earlier devices. 86 recalls are linked to its devices.

FDA’s records also spell it “Siemens Medical Solution, Inc. USA”.

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 Solution USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 22018: 12019: 22020: 22022: 1
2007high 2 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2008: 12014: 12016: 12018: 82019: 222020: 92021: 172022: 222023: 32024: 1
2007high 22 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Siemens Medical Solution USA, Inc.’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?

  • OWBInterventional Fluoroscopic X-Ray System3decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision
  • KPSSystem, Tomography, Computed, Emission1decision
  • MOSCoil, Magnetic Resonance, Specialty1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 74 days; 1 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 3 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.

  • K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 20186cite it
  • K163286ARTIS phenoSiemens Medical Solution USA, Inc. · 20174cite it
  • K050297Somatom Emotion 16Siemens Medical Solution, Inc. USA · 20054cite it
  • K193178Biograph HorizonSiemens Medical Solution USA, Inc. · 20202cite it
  • K190780syngo Application SoftwareSiemens Medical Solution USA, Inc. · 20191cites it
  • K163285syngo Application SoftwareSiemens Medical Solution USA, Inc. · 20171cites it

What has FDA decided for it lately?

  • K220433syngo Application Software (VE21)Siemens Medical Solution USA, Inc. · 2022
  • K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. · 20206 recalls
  • K193178Biograph HorizonSiemens Medical Solution USA, Inc. · 20201 recall
  • K190780syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2019
  • K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc. · 2019
  • K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 201859 recalls
  • K163286ARTIS phenoSiemens Medical Solution USA, Inc. · 201714 recalls
  • K163285syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2017

All 8 as Siemens Medical Solution USA, Inc. →All 3 as Siemens Medical Solution, Inc. USA →

What has been recalled?

86 recalls linked to its devices; the latest:

  • K181407Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor-…Mar 21, 2024Class II
  • K163286ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-…Feb 2, 2023Class II
  • K163286ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A…Feb 2, 2023Class II
  • K193178SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, EmissionJan 16, 2023Class II
  • K190768ARTIS pheno, ARTIS icono biplane, and ARTIS icono floorDec 16, 2022Class II
  • K181407System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee…Dec 16, 2022Class II