K252281
- 510(k) number
- K252281
- Device name
- ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- Applicant
- Ulrich GmbH & Co. KG DE
- Product code
- IZQ — Injector, Contrast Medium, Automatic
- Decision date
- 2025-11-18
- Date received
- 2025-07-22
- 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: K252281.pdf
Official FDA record: K252281
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.