510(k) Report

FDA applicant

Exini Diagnostics AB

Lund, SE4 decisions2012–20220 recalls

FDA records 4 decisions for Exini Diagnostics AB (Lund, SE) from 2012 to 2022: 4 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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 Exini Diagnostics AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12019: 12021: 12022: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Exini Diagnostics AB by year, 2012–2026Sources: 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, Radiological4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 60 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K122205EXINIExini Diagnostics AB · 20122cite it
  • K211655aPROMISEExini Diagnostics AB · 20211cites it
  • K191262aBSIExini Diagnostics AB · 20191cites it

What has FDA decided for it lately?

  • K220590aPROMISE XExini Diagnostics AB · 2022
  • K211655aPROMISEExini Diagnostics AB · 2021
  • K191262aBSIExini Diagnostics AB · 2019
  • K122205EXINIExini Diagnostics AB · 2012

All 4 as Exini Diagnostics AB →