K241849
- 510(k) number
- K241849
- Device name
- MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
- Applicant
- Imaxeon Pty, Ltd. AU
- Product code
- IZQ — Injector, Contrast Medium, Automatic
- Decision date
- 2024-11-05
- Date received
- 2024-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241849.pdf
Official FDA record: K241849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.