510(k) Report

FDA applicant

Siemens Corp.

Mchenry, IL84 decisions1978–201511 recalls

FDA records 84 decisions for Siemens Corp. (Mchenry, IL) from 1978 to 2015: 82 510(k) clearances and 2 original PMA approvals. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and KPR (System, X-Ray, Stationary). Its devices cite 38 predicates, 2 of them its own earlier devices. 11 recalls are linked to its devices.

FDA’s records also spell it “Siemens AG”, “Siemens”.

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 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12008: 12010: 12011: 12012: 12014: 12015: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2019

2015: 12016: 22017: 22018: 32019: 1
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Siemens 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?

  • JAKSystem, X-Ray, Tomography, Computed10decisions
  • KPRSystem, X-Ray, Stationary7decisions
  • IZOGenerator, High-Voltage, X-Ray, Diagnostic6decisions
  • IZFSystem, X-Ray, Tomographic4decisions
  • LLZSystem, Image Processing, Radiological4decisions
  • IZISystem, X-Ray, Angiographic4decisions

Also: KXJ (3), EHD (3), LNH (3), DSF (2), KPS (2), IXR (2).

Whose devices does it build on?

Its devices cite 38 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 57 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.

  • K071310Syngo CT Oncology Software PackageSiemens AG · 20077cite it
  • K150843syngo®.via (version VB10A)Siemens AG · 20155cite it
  • K963983E. Cam Profile Attenuation CorrectionSiemens Corp. · 19975cite it
  • K972312Siemens Orthophos DS/DS CephSiemens AG · 19974cite it
  • K110366Syngo.CT Cardiac FunctionSiemens AG · 20114cite it
  • P870018LithostarSiemens Corp. · 19883cite it

What has FDA decided for it lately?

  • K150843syngo®.via (version VB10A)Siemens AG · 2015
  • P110041Advia Centaur HbsagiiSiemens Corp. · 2014
  • K123375Syngo.ViaSiemens AG · 20128 recalls
  • K110366Syngo.CT Cardiac FunctionSiemens AG · 20111 recall
  • K103360Dimension Vista Digitoxin Calibrator - DGTX CalSiemens Corp. · 2010
  • K081182Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible ClindamycinSiemens · 2008
  • K071310Syngo CT Oncology Software PackageSiemens AG · 2007
  • K063507Syngo Neuro PBV CTSiemens AG · 2006

All 68 as Siemens Corp. →All 15 as Siemens AG →The one decision as Siemens →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K110366syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT…Mar 21, 2019Class II
  • K123375Syngo.Via VB20A model 1049610Mar 27, 2018Class II
  • K123375Syngo.via software is intended to be used for viewing, manipulation, communication, and…Jan 10, 2018Class II
  • K123375Syngo.via. Medical Device Software. Picture archiving and communications system.Jan 8, 2018Class II
  • K123375Syngo.via systems with SW VB20AAug 31, 2017Class II
  • K123375Syngo.via, Picture archiving and communication system Syngo via is a software solution…Mar 6, 2017Class II