# K252689: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

- Pathway: 510(k) (Special)
- Applicant: Imaxeon Pty, Ltd.
- Decided: Sep 24, 2025 after 29 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934086 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241849: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2), Imaxeon Pty, Ltd. (2024) Summary page 5.

## Indications for use
MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, via the venous route, of a contrast agent and 0.9% Sodium Chloride Injection USP (saline) to patients undergoing examinations in computed tomography (CT). The system is intended for use by and under direct quasi-continuous supervision of trained healthcare professionals to assure the integrity of the contrast agent and the injection system, in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent. For a complete list of compatible contrast agents for use with the MEDRAD® Centargo CT Injection System, refer to the Centargo CT Injection System Operation Manual. The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast agents, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast agent containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first. Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set. The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.

Source page: https://510kreport.com/device/K252689
Methodology: https://510kreport.com/methodology