510(k) Report

FDA applicant

Brainomix Limited

Oxford, GB13 decisions2020–20260 recalls

FDA records 13 decisions for Brainomix Limited (Oxford, GB) from 2020 to 2026: 13 510(k) clearances. Most are in product codes QAS (Radiological Computer-Assisted Triage And…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 4 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 Brainomix Limited’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2020: 12023: 62024: 12025: 42026 (partial year): 1
2020high 6 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Brainomix Limited by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QASRadiological Computer-Assisted Triage And Notification Software4decisions
  • LLZSystem, Image Processing, Radiological4decisions
  • POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 125 days; 6 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K192692Brainomix 360 e-CTABrainomix Limited · 20203cite it
  • K221564Brainomix 360 e-ASPECTSBrainomix Limited · 20232cite it
  • K233875Brainomix 360 e-LungBrainomix Limited · 20241cites it
  • K232496Brainomix 360 Triage StrokeBrainomix Limited · 20231cites it

What has FDA decided for it lately?

  • K260406Brainomix 360 HyperdensityBrainomix Limited · 2026
  • K251983Brainomix 360 Triage StrokeBrainomix Limited · 2025
  • K242411Brainomix 360 e-LungBrainomix Limited · 2025
  • K243294Brainomix 360 e-ASPECTSBrainomix Limited · 2025
  • K242123Brainomix 360 e-CTABrainomix Limited · 2025
  • K233875Brainomix 360 e-LungBrainomix Limited · 2024
  • K232496Brainomix 360 Triage StrokeBrainomix Limited · 2023
  • K231837Brainomix 360 Triage LVOBrainomix Limited · 2023

All 13 as Brainomix Limited →