5 devices · 2 companies · 2020 to 2024
GE Healthcare (Tianjin) Company Limited: AI-enabled devices on FDA's list
5 devices from GE Healthcare (Tianjin) Company Limited, 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 (5 of 5 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 |
|---|---|---|---|---|
| SIGNA ChampionK233728 · 510(k) | Radiology | LNH | database entry | |
| SIGNA VictorK223439 · 510(k) | Radiology | LNH | database entry | |
| SIGNA Artist EvoK213603 · 510(k) | Radiology | LNH | database entry | |
| SIGNA PrimeK211980 · 510(k) | Radiology | LNH | database entry | |
| SIGNA ArtistK202238 · 510(k) | Radiology | LNH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.