Medrad Stellant CT Injector System with Imaging System Interface Module

• • Terminated Z-0154-06 FDA Unclassified (pre-2012) ·initiated 10 Oct 2005

  the heat maintainer, an accessory, may overheat and deform the disposable syringe

510(k) Number

K033881 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Medrad, Inc. →

• What is the primary purpose of the Medrad Stellant CT Injector System, and how does it improve CT imaging procedures?

  The Medrad Stellant CT Injector System is designed to administer intravenous contrast media during computed tomography (CT) imaging, specifically for cardiovascular and other CT applications. It ensures precise and controlled injection of contrast agents, which enhances the clarity and diagnostic quality of the images by improving the visibility of blood vessels and tissues.

• Is the Medrad Stellant CT Injector System intended for single-use or reusable applications, and what are the maintenance requirements?

  The Medrad Stellant CT Injector System is intended for single-patient use, meaning each system is meant to be used once per patient. However, the core reusable components of the system require proper sterilization and maintenance as outlined in the manufacturer’s guidelines to ensure safe and effective reuse across multiple procedures.

• Does this device include any compatibility features for integration with CT scanners, and if so, what is their purpose?

  Yes, the Medrad Stellant CT Injector System includes an optional Imaging System Interface (ISI) module, which enables compatibility with CT scanners. This module facilitates seamless integration between the injector and imaging systems, allowing for synchronized contrast media delivery and optimized imaging workflows.

• How is the regulatory status of this device determined, and what classification does it fall under?

  The Medrad Stellant CT Injector System holds FDA 510K clearance, meaning it has been determined to be substantially equivalent to a legally marketed device. It is classified under Device Class 2 (DXT) and regulated under 21 CFR 870.1650, reflecting its role as an injector and syringe for angiographic applications.

• Are there any specific storage or handling instructions for this device beyond standard medical equipment protocols?

  While the provided data does not specify detailed storage instructions beyond general medical equipment protocols, the reusable components of the Medrad Stellant CT Injector System require adherence to the manufacturer’s sterilization and maintenance guidelines to ensure functionality and safety. Proper handling and storage are critical to prevent contamination and maintain performance.