3 devices · 3 companies · 2020 to 2025
Scopio Labs , Ltd.: AI-enabled devices on FDA's list
3 devices from Scopio Labs , Ltd., 2020 to 2025, from 3 companies across 1 product code. 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.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| X100/X100HT with Full Field Peripheral Blood SmeK243144 · 510(k) | Hematology | JOY | database entry | |
| X100HT with Slide Loader with Full Field PeripheK220013 · 510(k) | Hematology | JOY | database entry | |
| X100 with Full Field Peripheral Blood SmearK201301 · 510(k) | Hematology | JOY | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.