Clearance Summary
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) received FDA 510(k) clearance under submission number K241849, sponsored by Imaxeon Pty, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-11-05.
- Submission: K241849
- Applicant / Sponsor: Imaxeon Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2024-11-05
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.