3 devices · 3 companies · 2021 to 2025
Eko.Ai Pte Ltd. D/B/A Us2.Ai: AI-enabled devices on FDA's list
3 devices from Eko.Ai Pte Ltd. D/B/A Us2.Ai, 2021 to 2025, from 3 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Eko.Ai Pte Ltd. D/B/A Us2.Ai
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Us2.caK250151 · 510(k) | Cardiovascular | SDJ | database entry | |
| Us2.v2K233676 · 510(k) | Radiology | QIH | database entry | |
| Us2.v1K210791 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.