8 devices · 2 companies · 2019 to 2026
Ge Healthcare Japan Corporation: AI-enabled devices on FDA's list
8 devices from Ge Healthcare Japan Corporation, 2019 to 2026, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 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 |
|---|---|---|---|---|
| True Definition DLK253686 · 510(k) | Radiology | JAK | database entry | |
| True Enhance DLK233698 · 510(k) | Radiology | JAK | database entry | |
| Deep Learning Image ReconstructionK230807 · 510(k) | Radiology | JAK | database entry | |
| Deep Learning Image ReconstructionK220961 · 510(k) | Radiology | JAK | database entry | |
| Revolution AscendK213938 · 510(k) | Radiology | JAK | database entry | |
| Deep Learning Image ReconstructionK212067 · 510(k) | Radiology | JAK | database entry | |
| Revolution AscendK203169 · 510(k) | Radiology | JAK | database entry | |
| Deep Learning Image ReconstructionK193170 · 510(k) | Radiology | JAK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.