3 devices · 1 company · 2021 to 2026
Elekta Solutions AB: AI-enabled devices on FDA's list
3 devices from Elekta Solutions AB, 2021 to 2026, from 1 company across 3 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 Elekta Solutions AB
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Monaco RTP SystemK252002 · 510(k) | Radiology | MUJ | database entry | |
| EMLAK252188 · 510(k) | Radiology | IYE | database entry | |
| Advanced Algorithms for Treatment Management AppK212218 · 510(k) | Radiology | QKB | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.