# K241849: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

- Pathway: 510(k) (Traditional)
- Applicant: Imaxeon Pty, Ltd.
- Decided: Nov 5, 2024 after 131 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: 4 generations back to K934086 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151048: CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set, Bracco Injeneering (2016) Summary page 6.

## Most influential descendants
- K252689: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (2025), 0 descendants of its own

## Indications for use
MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, on the venous side, of ULTRAVIST® (lopromide), ISOVUE® (lopamidol), OPTIRAY® (loversol) or OMNIPAQUE™ (lohexol) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing examinations in computed tomography (CT). The system is to be used by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent. The Day Set is used for a maximum time of twenty four (24) hours, or for a maximum of 25 bottles of contrast media, 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 media 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/K241849
Methodology: https://510kreport.com/methodology