Brainomix Limited: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Brainomix Limited” (first 2020, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 123 days. Since 2017 the median was 123 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 245 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 6 | 97 |
| 2024 | 1 | 158 |
| 2025 | 4 | 145 |
| 2026 | 1 | 123 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Brainomix Limited took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 4 | 4 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (13)
Most recent Brainomix Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260406 | Brainomix 360 Hyperdensity | QIH | 2026-06-12 | 123 |
| K251983 | Brainomix 360 Triage Stroke | QAS | 2025-08-26 | 60 |
| K242411 | Brainomix 360 e-Lung | JAK | 2025-02-19 | 189 |
| K243294 | Brainomix 360 e-ASPECTS | POK | 2025-02-14 | 119 |
| K242123 | Brainomix 360 e-CTA | LLZ | 2025-01-06 | 171 |
| K233875 | Brainomix 360 e-Lung | JAK | 2024-05-13 | 158 |
| K232496 | Brainomix 360 Triage Stroke | QAS | 2023-11-21 | 96 |
| K231837 | Brainomix 360 Triage LVO | QAS | 2023-09-28 | 98 |
| K231656 | Brainomix 360 e-MRI | LLZ | 2023-08-30 | 84 |
| K231195 | Brainomix 360 Triage ICH | QAS | 2023-07-27 | 91 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Brainomix Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Brainomix Limited?
FDA lists 13 510(k) clearances under the applicant name “Brainomix Limited” (first 2020, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Brainomix Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brainomix Limited is 123 days. Since 2017: 123 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Brainomix Limited?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); QAS (Radiological Computer-Assisted Triage And Notification Software, 4); JAK (System, X-Ray, Tomography, Computed, 2).
Next steps
- See all 13 Brainomix Limited clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Brainomix Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.