510(k) Report

FDA applicant

Siemens AG Healthcare

Erlangen, DE1 decision2013–201311 recalls

FDA records 1 decision for Siemens AG Healthcare (Erlangen, DE) in 2013: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 11 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 AG Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2018

2014: 12015: 32016: 22017: 32018: 2
2013high 3 (2015) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Siemens AG Healthcare by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K132532Syngo.Plaza VB10ASiemens AG Healthcare · 20132cite it

What has FDA decided for it lately?

  • K132532Syngo.Plaza VB10ASiemens AG Healthcare · 201311 recalls

The one decision as Siemens AG Healthcare →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K132532Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS)…Feb 20, 2018Class II
  • K132532Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a…Feb 20, 2018Class II
  • K132532Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product…Aug 23, 2017Class II
  • K132532Syngo.plaza Picture Archiving and Communication System (PACS) with software version…Aug 18, 2017Class II
  • K132532Syngo.plaza, Picture Archiving and Communications System (PACS), Model 10863171…May 22, 2017Class II
  • K132532Syngo.plaza VB10A, Picture Archiving and Communication SystemSep 6, 2016Class II