3 devices · 2 companies · 2024 to 2026
Medtronic Navigation, Inc.: AI-enabled devices on FDA's list
3 devices from Medtronic Navigation, Inc., 2024 to 2026, from 2 companies 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 Medtronic Navigation, Inc.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Stealth AXiS Cranial clinical applicationK253379 · 510(k) | Neurology | HAW | database entry | |
| Stealth AXiS Surgical System with Stealth AXiS SK253381 · 510(k) | Neurology | OLO | database entry | |
| O-arm O2 Imaging SystemK240465 · 510(k) | Radiology | OWB | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.