2 devices · 1 company · 2025 to 2026
Smart Alfa Teknoloji San. Ve Tic. A.S.: AI-enabled devices on FDA's list
2 devices from Smart Alfa Teknoloji San. Ve Tic. A.S., 2025 to 2026, from 1 company across 2 product codes. 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.
Product codes from Smart Alfa Teknoloji San. Ve Tic. A.S.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| MSK GoK260234 · 510(k) | Radiology | QIH | database entry | |
| NervebloxK250818 · 510(k) | Anesthesiology | QRG | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.