510(k) Report

FDA applicant

Arcoma AB

Vaxjo, SE2 decisions2008–20142 recalls

FDA records 2 decisions for Arcoma AB (Vaxjo, SE) from 2008 to 2014: 2 510(k) clearances. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 4 predicates, 1 of them its own earlier devices. 2 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 Arcoma AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 12014: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2021

2021: 2
2008high 2 (2021) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Arcoma AB by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPRSystem, X-Ray, Stationary2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K073632Intuition, Model 0170Arcoma AB · 20082cite it

What has FDA decided for it lately?

  • K1406830180 Intuition, 0072 PrecisionArcoma AB · 20142 recalls
  • K073632Intuition, Model 0170Arcoma AB · 2008

All 2 as Arcoma AB →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K140683Omnera 400A Digital Radiographic SystemMay 5, 2021Class II
  • K140683Omnera 400T Digital Radiographic SystemMay 5, 2021Class II