510(k) Report

FDA applicant

Siemens Medical Systems USA, Inc.

Malvern, PA3 decisions2012–20218 recalls

FDA records 3 decisions for Siemens Medical Systems USA, Inc. (Malvern, PA) from 2012 to 2021: 3 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and LLZ (System, Image Processing, Radiological). Its devices cite 9 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Siemens Medical Systems 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 Systems USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2012: 12018: 12021: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2023

2019: 22020: 52023: 1
2012high 5 (2020) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Systems USA, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Siemens Medical Systems 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 System2decisions
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K210054Cios SpinSiemens Medical Systems USA, Inc. · 20213cite it
  • K181560Cios AlphaSiemens Medical Systems USA, Inc. · 20182cite it

What has FDA decided for it lately?

  • K210054Cios SpinSiemens Medical Systems USA, Inc. · 20211 recall
  • K181560Cios AlphaSiemens Medical Systems USA, Inc. · 20187 recalls
  • K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA · 2012

All 2 as Siemens Medical Systems USA, Inc. →The one decision as Siemens Medical Systems USA →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K203504***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System.…Sep 12, 2023Class II
  • K181560Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are…Jul 30, 2020Class II
  • K181550Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30)…Jul 14, 2020Class II
  • K181560Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios…Apr 20, 2020Class II
  • K181560Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios…Apr 20, 2020Class II
  • K181560Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and…Apr 17, 2020Class II