8 devices · 1 company · 2023 to 2026
Brainomix Limited: AI-enabled devices on FDA's list
8 devices from Brainomix Limited, 2023 to 2026, from 1 company across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Brainomix Limited
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Brainomix 360 HyperdensityK260406 · 510(k) | Radiology | QIH | database entry | |
| Brainomix 360 Triage StrokeK251983 · 510(k) | Radiology | QAS | database entry | |
| Brainomix 360 e-ASPECTSK243294 · 510(k) | Radiology | POK | database entry | |
| Brainomix 360 e-CTAK242123 · 510(k) | Radiology | LLZ | database entry | |
| Brainomix 360 Triage StrokeK232496 · 510(k) | Radiology | QAS | database entry | |
| Brainomix 360 Triage LVOK231837 · 510(k) | Radiology | QAS | database entry | |
| Brainomix 360 Triage ICHK231195 · 510(k) | Radiology | QAS | database entry | |
| Brainomix 360 e-ASPECTSK221564 · 510(k) | Radiology | POK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.