# Brainomix Limited

- Location (FDA's records): Oxford, GB
- FDA decisions: 13 (2020–2026): 13 510(k) clearances
- Product codes: QAS (4), LLZ (4), POK (2), JAK (2), QIH (1)
- 510(k) review time since 2016: median 121 days, against 125 for FDA's reviews in the same codes and years (6 of 12 faster)
- Predicates its devices cite: 14 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ischemaview, Inc.: 6 (https://510kreport.com/company/ischemaview)
- Viz. Ai, Inc.: 3 (https://510kreport.com/company/viz-ai)
- Vida Diagnostics, Inc.: 1 (https://510kreport.com/company/vida-diagnostics)

## Firms that cite its devices most
- Circle Cardiovascular Imaging, Inc.: 1 (https://510kreport.com/company/circle-cardiovascular-imaging)
- Serv Medical Pte., Ltd.: 1 (https://510kreport.com/company/serv-medical)
- Yukun (Beijing) Technology Co., Ltd.: 1 (https://510kreport.com/company/yukun-beijing-technology)

## Its most-cited devices
- K192692: Brainomix 360 e-CTA (2020), cited by 3
- K221564: Brainomix 360 e-ASPECTS (2023), cited by 2
- K233875: Brainomix 360 e-Lung (2024), cited by 1
- K232496: Brainomix 360 Triage Stroke (2023), cited by 1

## Recent decisions
- K260406: Brainomix 360 Hyperdensity (Jun 12, 2026)
- K251983: Brainomix 360 Triage Stroke (Aug 26, 2025)
- K242411: Brainomix 360 e-Lung (Feb 19, 2025)
- K243294: Brainomix 360 e-ASPECTS (Feb 14, 2025)
- K242123: Brainomix 360 e-CTA (Jan 6, 2025)
- K233875: Brainomix 360 e-Lung (May 13, 2024)
- K232496: Brainomix 360 Triage Stroke (Nov 21, 2023)
- K231837: Brainomix 360 Triage LVO (Sep 28, 2023)

Source page: https://510kreport.com/company/brainomix