13 devices · 2 companies · 2014 to 2025
GE Medical Systems SCS: AI-enabled devices on FDA's list
13 devices from GE Medical Systems SCS, 2014 to 2025, 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 (13 of 13 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from GE Medical Systems SCS
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| CardIQ SuiteK243672 · 510(k) | Radiology | JAK | database entry | |
| VersaViewerK243651 · 510(k) | Radiology | LLZ | database entry | |
| 3DXRK243446 · 510(k) | Radiology | OWB | database entry | |
| CardIQ SuiteK233731 · 510(k) | Radiology | JAK | database entry | |
| Spine Auto ViewsK223424 · 510(k) | Radiology | JAK | database entry | |
| FlightPlan for EmbolizationK223490 · 510(k) | Radiology | LLZ | database entry | |
| CardIQ SuiteK213725 · 510(k) | Radiology | JAK | database entry | |
| FlightPlan for LiverK210807 · 510(k) | Radiology | LLZ | database entry | |
| PROViewK193306 · 510(k) | Radiology | LLZ | database entry | |
| FastStroke, CT Perfusion 4DK193289 · 510(k) | Radiology | JAK | database entry | |
| Hepatic VCARK193281 · 510(k) | Radiology | JAK | database entry | |
| Bone VCARK183204 · 510(k) | Radiology | JAK | database entry | |
| HEPATIC VCARK133649 · 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.