Brainomix Limited
Oxford Oxfordshire, GB
BRAINOMIX LIMITED appears in FDA device records in Oxford Oxfordshire, GB. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Brainomix Limited between 2020 and 2026. The busiest year on record is 2023, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2023 | 6 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260406 | Brainomix 360 Hyperdensity | QIH | Substantially Equivalent | |
| K251983 | Brainomix 360 Triage Stroke | QAS | Substantially Equivalent | |
| K242411 | Brainomix 360 e-Lung | JAK | Substantially Equivalent | |
| K243294 | Brainomix 360 e-ASPECTS | POK | Substantially Equivalent | |
| K242123 | Brainomix 360 e-CTA | LLZ | Substantially Equivalent | |
| K233875 | Brainomix 360 e-Lung | JAK | Substantially Equivalent | |
| K232496 | Brainomix 360 Triage Stroke | QAS | Substantially Equivalent | |
| K231837 | Brainomix 360 Triage LVO | QAS | Substantially Equivalent | |
| K231656 | Brainomix 360 e-MRI | LLZ | Substantially Equivalent | |
| K231195 | Brainomix 360 Triage ICH | QAS | Substantially Equivalent | |
| K223555 | Brainomix 360 e-CTP | LLZ | Substantially Equivalent | |
| K221564 | Brainomix 360 e-ASPECTS | POK | Substantially Equivalent | |
| K192692 | Brainomix 360 e-CTA | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017210169 | 3017210169 | BRAINOMIX LIMITED | First Floor, Seacourt tower, Oxford Oxfordshire OX2 0JJ GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain