2 devices · 2 companies · 2020 to 2024
GE Hangwei Medical Systems Co., Ltd.: AI-enabled devices on FDA's list
2 devices from GE Hangwei Medical Systems Co., Ltd., 2020 to 2024, 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 (2 of 2 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 |
|---|---|---|---|---|
| Revolution Ascend SlidingK233749 · 510(k) | Radiology | JAK | database entry | |
| Auto PositioningK192956 · 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.