510(k) Report

FDA applicant

Brainreader Aps

Egaa, DK1 decision2015–20151 recall

FDA records 1 decision for Brainreader Aps (Egaa, DK) in 2015: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Brainreader Aps’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2015high 1 (2020) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Brainreader Aps by year, 2015–2026Sources: 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, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K140828Neuroreader Medical Image Processing SoftwareBrainreader Aps · 20151cites it

What has FDA decided for it lately?

  • K140828Neuroreader Medical Image Processing SoftwareBrainreader Aps · 20151 recall

The one decision as Brainreader Aps →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140828Neuroreader Medical Image Processing Software - Product Usage: intended to automate the…Dec 14, 2020Class II