510(k) Report

FDA applicant

Siemens Medical Corp.

Iselin, NJ5 decisions1999–200126 recalls

FDA records 5 decisions for Siemens Medical Corp. (Iselin, NJ) from 1999 to 2001: 5 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 6 predicates, 0 of them its own earlier devices. 26 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 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens Medical Corp. since 2007.

Recalls per year

1in 2017

2007: 22008: 102009: 22010: 12014: 12015: 12016: 12017: 1
2007high 10 (2008) · low 0 (2011)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • ODAEndoscopic Central Control Unit1decision
  • IZISystem, X-Ray, Angiographic1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 20002cite it
  • K010721Axiom Artis Modular Angiography SystemSiemens Medical Corp. · 20012cite it
  • K9846343D-AngioSiemens Medical Corp. · 19991cites it

What has FDA decided for it lately?

  • K012202Numaris 4VA15ASiemens Medical Corp. · 2001
  • K010721Axiom Artis Modular Angiography SystemSiemens Medical Corp. · 200126 recalls
  • K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
  • K994316Magnetom Open Viva with Permanent MagnetSiemens Medical Corp. · 2000
  • K9846343D-AngioSiemens Medical Corp. · 1999

All 5 as Siemens Medical Corp. →

What has been recalled?

26 recalls linked to its devices; the latest:

  • K052202Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model…Sep 28, 2017Class II
  • K010721AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis…Jul 13, 2016Class II
  • K010721Axiom Artis systems, dedicated angiography systems developed for single and biplane…Jun 29, 2015Class II
  • K010721AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are…Jun 5, 2014Class II
  • K010721AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.Jul 13, 2010
  • K010721Axiom Artis MP, Model number 5904466 angiographic x-ray systemsOct 26, 2009