3 devices · 1 company · 2019 to 2022
EXINI Diagnostics AB: AI-enabled devices on FDA's list
3 devices from EXINI Diagnostics AB, 2019 to 2022, from 1 company 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 |
|---|---|---|---|---|
| aPROMISE XK220590 · 510(k) | Radiology | LLZ | database entry | |
| aPROMISEK211655 · 510(k) | Radiology | LLZ | database entry | |
| aBSIK191262 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.