510(k) Report

FDA applicant

Eos Imaging

Paris, FR17 decisions2012–20254 recalls

FDA records 17 decisions for Eos Imaging (Paris, FR) from 2012 to 2025: 17 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 16 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Eos 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 Eos Imaging’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2012: 22013: 22014: 12015: 22016: 12018: 12019: 12020: 12023: 12024: 32025: 2
2012high 3 (2024) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2020

2013: 12015: 12018: 12020: 1
2012high 1 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Eos Imaging by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eos Imaging’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?

  • LLZSystem, Image Processing, Radiological6decisions
  • KPRSystem, X-Ray, Stationary5decisions
  • QIHAutomated Radiological Image Processing Software4decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 5 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 16 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.

  • K172346sterEOS WorkstationEos Imaging · 20183cite it
  • K240582VEA Align; spineEOSEos Imaging · 20242cite it
  • K251747VEA Align; spineEOSEos Imaging · 20251cites it
  • K130395Stereos WorkstationEos Imaging, Inc. · 20131cites it
  • K142773EOS SystemEos Imaging · 20151cites it
  • K160914sterEOS WorkstationEos Imaging, Inc. · 20161cites it

What has FDA decided for it lately?

  • K251078AutoDensityEos Imaging · 2025
  • K251747VEA Align; spineEOSEos Imaging · 2025
  • K233920EOSedgeEos Imaging · 2024
  • K240582VEA Align; spineEOSEos Imaging · 2024
  • K231917VEA AlignEos Imaging · 2024
  • K232086spineEOSEos Imaging · 2023
  • K202394EOSedgeEos Imaging · 20201 recall
  • K192079EOSedgeEos Imaging · 2019

All 15 as Eos Imaging →All 2 as Eos Imaging, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K202394The EOSedge system may acquire two simultaneous orthogonal planar images for a standing…Dec 22, 2020Class II
  • K172346sterEOS workstationAug 1, 2018Class II
  • K123740EOS, Digital radiography system used in general radiographic examinations.Feb 17, 2015Class II
  • K130395steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D…Nov 29, 2013Class II