K252689 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 September 24, 2025, 29 days after receiving the submission on August 26, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K252689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2025 |
| Decision Date | September 24, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |