Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K243605
Aurora · Ge Medical Systems Israel, Functional Imaging · decided 2025-01-17 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Aurora | SPECT with Revolution Ascend CT | GE Medical Systems Israel, Functional Imaging | JAK KPS | 00195278878502 |