510(k) Report

FDA applicant

Icometrix NV

Leuven, BE6 decisions2016–20240 recalls

FDA records 6 decisions for Icometrix NV (Leuven, BE) from 2016 to 2024: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QBS (Radiological Computer Assisted…). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Icometrix”.

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 Icometrix NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 12018: 22019: 12020: 12024: 1
2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Icometrix NV by year, 2016–2026Sources: 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, Radiological5decisions
  • QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 110 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K192130IcobrainIcometrix NV · 20193cite it
  • K161148icobrainIcometrix · 20162cite it
  • K181939icobrainIcometrix NV · 20182cite it
  • K180326icobrainIcometrix · 20181cites it

What has FDA decided for it lately?

  • K240712icobrain ariaIcometrix NV · 2024
  • K192962icobrain-ctpIcometrix NV · 2020
  • K192130IcobrainIcometrix NV · 2019
  • K181939icobrainIcometrix NV · 2018
  • K180326icobrainIcometrix · 2018
  • K161148icobrainIcometrix · 2016

All 4 as Icometrix NV →All 2 as Icometrix →