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Brainomix

Medical device makerAI in United KingdomAI. FDA records under 2 spellings of its name, each linked to the record.

  • 510(k) clearances: 13
  • AI-enabled devices: 8

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Jun 12, 2026Brainomix 360 HyperdensityK260406 · QIH510(k) clearances
Jun 12, 2026Brainomix 360 HyperdensityK260406 · RadiologyAI-enabled devices
Aug 26, 2025Brainomix 360 Triage StrokeK251983 · QAS510(k) clearances
Aug 26, 2025Brainomix 360 Triage StrokeK251983 · RadiologyAI-enabled devices
Feb 19, 2025Brainomix 360 e-LungK242411 · JAK510(k) clearances
Feb 14, 2025Brainomix 360 e-ASPECTSK243294 · POK510(k) clearances
Feb 14, 2025Brainomix 360 e-ASPECTSK243294 · RadiologyAI-enabled devices
Jan 6, 2025Brainomix 360 e-CTAK242123 · LLZ510(k) clearances
Jan 6, 2025Brainomix 360 e-CTAK242123 · RadiologyAI-enabled devices
May 13, 2024Brainomix 360 e-LungK233875 · JAK510(k) clearances
Nov 21, 2023Brainomix 360 Triage StrokeK232496 · QAS510(k) clearances
Nov 21, 2023Brainomix 360 Triage StrokeK232496 · RadiologyAI-enabled devices
Sep 28, 2023Brainomix 360 Triage LVOK231837 · QAS510(k) clearances
Sep 28, 2023Brainomix 360 Triage LVOK231837 · RadiologyAI-enabled devices
Jul 27, 2023Brainomix 360 Triage ICHK231195 · RadiologyAI-enabled devices
Feb 23, 2023Brainomix 360 e-ASPECTSK221564 · RadiologyAI-enabled devices

Names and Identifiers

Appears as
Brainomix Limited

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.