510(k) Report

FDA applicant

Ziehm Imaging GmbH

Nuremberg, DE25 decisions2005–202520 recalls

FDA records 25 decisions for Ziehm Imaging GmbH (Nuremberg, DE) from 2005 to 2025: 25 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 148 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 25 of them its own earlier devices. 20 recalls are linked to its devices.

FDA’s records also spell it “Ziehm Imaging, Inc.”.

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 Ziehm Imaging GmbH’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2008: 12009: 22013: 12015: 12016: 12019: 22020: 12021: 12023: 42024: 32025: 4
2007high 4 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2024

2011: 12013: 52016: 62017: 12024: 7
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ziehm Imaging GmbH’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?

  • OWBInterventional Fluoroscopic X-Ray System21decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions

How long do its 510(k) reviews take?

Since 2016, its 16 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 148 days; 11 of its 16 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 25 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.

  • K073346Ziehm Vision 2Ziehm Imaging, Inc. · 20084cite it
  • K132904Ziehm Vision RFDZiehm Imaging GmbH · 20133cite it
  • K142740Ziehm Vision RFD 3DZiehm Imaging GmbH · 20153cite it
  • K061534Ziehm Vision FD Digital Mobile Imaging SystemZiehm Imaging, Inc. · 20062cite it
  • K161976Ziehm Solo FDZiehm Imaging GmbH · 20162cite it
  • K243303Ziehm Vision RFD 3DZiehm Imaging GmbH · 20252cite it

What has FDA decided for it lately?

  • K243646Ziehm Solo FDZiehm Imaging GmbH · 2025
  • K243735Ziehm Vision FDZiehm Imaging GmbH · 2025
  • K243303Ziehm Vision RFD 3DZiehm Imaging GmbH · 2025
  • K243328Ziehm Vision RFDZiehm Imaging GmbH · 2025
  • K240099Ziehm Vision RFDZiehm Imaging GmbH · 20241 recall
  • K240020Ziehm Vision FDZiehm Imaging GmbH · 20241 recall
  • K234109Ziehm Solo FDZiehm Imaging GmbH · 20241 recall
  • K231700Ziehm Vision FDZiehm Imaging GmbH · 2023

All 18 as Ziehm Imaging GmbH →All 7 as Ziehm Imaging, Inc. →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K073346Ziehm Vision system, x-ray, tomography, computed.Aug 8, 2024Class II
  • K092438Ziehm Solo. Digital Mobile C-armAug 8, 2024Class II
  • K234109Ziehm Solo FD. Interventional fluoroscopic x-ray systemAug 8, 2024Class II
  • K240020Ziehm Vision FD. Interventional fluoroscopic x-ray systemAug 8, 2024Class II
  • K061203Ziehm Vision R. Iterventional fluoroscopic x-ray systemAug 8, 2024Class II
  • K240099Ziehm Vision RFD. Interventional fluoroscopic x-ray systemAug 8, 2024Class II

Other applicant names beginning “Ziehm”

FDA records each applicant name separately; these may or may not be the same firm.

Ziehm International, Inc. 16Ziehm-Orthoscan, Inc. 3