K241849 is an FDA 510(k) clearance for the MEDRAD Centargo CT Injection System. This device is classified as a Injector, Contrast Medium, Automatic (Class II - Special Controls, product code IZQ).
Submitted by Imaxeon Pty, Ltd. (Rydalmere, AU). The FDA issued a Cleared decision on November 5, 2024, 131 days after receiving the submission on June 27, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K241849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2024 |
| Decision Date | November 05, 2024 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | IZQ - Injector, Contrast Medium, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |