K251295 is an FDA 510(k) clearance for the ulrichINJECT CT Motion (XD 8000). This device is classified as a Injector, Contrast Medium, Automatic (Class II - Special Controls, product code IZQ).
Submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on November 7, 2025, 196 days after receiving the submission on April 25, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K251295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2025 |
| Decision Date | November 07, 2025 |
| Days to Decision | 196 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 |