510(k) Report

FDA applicant

Imix Adr Finland OY

Naples, FL4 decisions2007–20120 recalls

FDA records 4 decisions for Imix Adr Finland OY (Naples, FL) from 2007 to 2012: 4 510(k) clearances. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 11 predicates, 2 of them its own earlier devices. No recall is 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 Imix Adr Finland OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Imix Adr Finland OY by year, 2007–2026Sources: 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, Stationary4decisions

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073114Imix Insight X-Ray SystemsImix Adr Finland OY · 20081cites it
  • K101435Imix Panorad and SomaradImix Adr Finland OY · 20101cites it

What has FDA decided for it lately?

  • K113855Panorad, Panorad SLImix Adr Finland OY · 2012
  • K101435Imix Panorad and SomaradImix Adr Finland OY · 2010
  • K073114Imix Insight X-Ray SystemsImix Adr Finland OY · 2008
  • K072867Imix 2000 Digital Radiography System, Models Unv 3K, Unv 3KW, Unv 4KImix Adr Finland OY · 2007

All 4 as Imix Adr Finland OY →