K251295
- 510(k) number
- K251295
- Device name
- ulrichINJECT CT Motion (XD 8000)
- Applicant
- Ulrich GmbH & Co. KG DE
- Product code
- IZQ — Injector, Contrast Medium, Automatic
- Decision date
- 2025-11-07
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251295.pdf
Official FDA record: K251295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.