MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
Imaxeon Pty LtdThe MEDRAD Centargo CT Injection System is an automated device used to inject contrast media and saline into patients during CT scans. It helps radiology professionals by providing controlled, precise, and programmable delivery of contrast agents, improving diagnostic imaging quality while ensuring patient safety through features like air detection and occlusion monitoring.
Intended Use
Automated contrast injection system for controlled, automatic administration, on the venous side, of various approved iodinated contrast media and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing CT examinations.
Technology
The system uses a piston-based electromechanical device to deliver contrast and saline through disposable sets with multiple sensors for air detection. It includes a Scan Room Unit and a Control Room Unit that can communicate wired/wirelessly. It supports scanner connectivity options via the ISI2 Module and software for smart injection protocols.
Performance
Performance testing included verification of injection volume and flow accuracy, pressure accuracy, air detection, heat maintenance, battery life, occlusion detection, protocol management, software validation, cybersecurity, biocompatibility, chemical compatibility, cleaning/disinfection, sterilization, contamination control, usability, reliability, and EMC/electrical safety testing. All tests met acceptance criteria, demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/27/2024
4 months - 2
FDA Approval
11/5/2024
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