← Back to catalogue

MEDRAD Centargo CT Injection System - MEDRAD Centargo Patient Line

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252689

by Imaxeon Pty Ltd

Identifiers

510(k) Number
K252689 FDA 510(k)
FDA Product Code
IZQ FDA 510(k)
Models / Variants
MEDRAD Centargo CT Injection System FDA 510(k)EUDAMED
MEDRAD Centargo Day Set FDA 510(k)EUDAMED
MEDRAD Centargo Patient Line FDA 510(k)EUDAMED
MEDRAD Centargo Replacement Spike FDA 510(k)EUDAMED
MEDRAD ISI2 Module (ISI2) FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1650 FDA 510(k)
Regulation Number
870.1650 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MEDRAD Centargo CT Injection System is an Automatic Injector for Contrast Medium, designed to deliver intravenous contrast agents during computed tomography (CT) scans. It ensures precise, programmable infusion rates to enhance image quality and diagnostic accuracy in cardiovascular and other CT imaging procedures. The system integrates with compatible CT scanners to automate contrast delivery, reducing operator variability and improving workflow efficiency.

This device is supplied as a reusable system with single-use consumables, including the Day Set, Patient Line, and Replacement Spike, which are intended for one-time use. The MEDRAD ISI2 Module (ISI2) is a key component for injection control and monitoring. The system is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDR authorization. It is intended for use in clinical settings where contrast-enhanced CT imaging is performed, adhering to standard sterility and safety protocols for medical imaging devices.

Frequently asked questions

What types of consumables are included with the MEDRAD Centargo CT Injection System, and how are they used?

The MEDRAD Centargo CT Injection System includes single-use consumables such as the Day Set, Patient Line, and Replacement Spike, which are designed for one-time use per patient. These components connect to the reusable injector system to deliver intravenous contrast agents during CT scans, ensuring sterile and contamination-free administration. The Day Set is likely a pre-assembled set of tubing and connectors, while the Patient Line and Replacement Spike provide flexibility for different patient needs or setup configurations.

Is the MEDRAD Centargo CT Injection System reusable, and if so, what maintenance or cleaning requirements should be considered?

Yes, the MEDRAD Centargo CT Injection System itself is reusable, while its consumables (Day Set, Patient Line, Replacement Spike) are single-use. Since it is a reusable device, proper cleaning, disinfection, and maintenance per manufacturer guidelines are essential to ensure reliability, sterility, and longevity. The system’s reusable components, such as the ISI2 Module, must be handled according to the manufacturer’s instructions to avoid cross-contamination and maintain performance for repeated use in clinical settings.

How does the MEDRAD Centargo CT Injection System integrate with CT scanners, and what makes its infusion control unique?

The MEDRAD Centargo CT Injection System is designed to integrate with compatible CT scanners to automate the delivery of intravenous contrast agents during imaging. Its infusion control is managed by the MEDRAD ISI2 Module (ISI2), which allows for precise, programmable infusion rates tailored to specific CT protocols. This automation reduces operator variability, enhances image quality, and improves workflow efficiency—particularly valuable in cardiovascular and other contrast-enhanced CT procedures where timing and dosage accuracy are critical.

What regulatory pathways has the MEDRAD Centargo CT Injection System followed, and how does this affect its use in clinical settings?

The system has undergone FDA 510(k) clearance and holds MDR (Medical Device Regulation) authorization, confirming its compliance with stringent safety and performance standards. These regulatory pathways ensure that the device meets requirements for Class II classification under FDA regulations and adheres to European medical device directives. Clinically, this means the system is validated for use in settings where contrast-enhanced CT imaging is performed, with adherence to standard sterility and safety protocols already established by regulatory bodies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Imaxeon Pty Ltd
FDA Applicant
Imaxeon Pty, Ltd.

Sources (2)

  • FDA 510(k) K252689 24 fields · synced Oct 7, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026