K252891
- 510(k) number
- K252891
- Device name
- MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
- Applicant
- Bayer Medical Care, Inc. PA · US
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2026-02-13
- Date received
- 2025-09-11
- 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: K252891.pdf
Official FDA record: K252891
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.