2 devices · 2 companies · 2025 to 2026
Earlitec Diagnostics: AI-enabled devices on FDA's list
2 devices from Earlitec Diagnostics, 2025 to 2026, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| EarliPoint AssessmentK253442 · 510(k) | Neurology | QPF | database entry | |
| EarliPoint SystemK243891 · 510(k) | Neurology | QPF | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.