Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Floor Stand | 016204 | Bracco Injeneering SA | IZQ | 37630039300402 |
| EmpowerMR® Injector System without Remote Control | 017377 | Bracco Injeneering SA | IZQ | 47630039300973 |
| FastLoad™ MR Syringe Pack | 017356 | Bracco Injeneering SA | IZQ | 17630039300866 |
| Remote Control | 017380 | Bracco Injeneering SA | IZQ | 17630039301030 |
| Hydraulic Controller | 017378 | Bracco Injeneering SA | IZQ | 17630039300385 |
| Remote Control | 017380 | Bracco Injeneering SA | IZQ | 17630039300378 |
| FastLoad™ MR Syringe Pack | 017348 | Bracco Injeneering SA | IZQ | 17630039300293 |
| Accessory Kit | 017381 | Bracco Injeneering SA | IZQ | 37630039300730 |
| Empower MR Injector Head | 017377 | Bracco Injeneering SA | IZQ | 17630039301016 |
| Penetration Panel | 017382 | Bracco Injeneering SA | IZQ | 37630039300419 |
| FastLoad™ MR Syringe Pack | 017348 | Bracco Injeneering SA | IZQ | 17630039301627 |
| EmpowerMR® Injector System without Remote Control | 017377 | Bracco Injeneering SA | IZQ | 47630039300751 |
| Electro-Hydraulic Interconnect | 017379 | Bracco Injeneering SA | IZQ | 17630039300361 |
| Hydraulic Controller | 017378 | Bracco Injeneering SA | IZQ | 17630039300996 |
| Injector head | 017377 | Bracco Injeneering SA | IZQ | 17630039300392 |
| Remote Control | 017380 | Bracco Injeneering SA | IZQ | 17630039300781 |