FDA Product Code IZQ: Injector, Contrast Medium, Automatic
Under FDA product code IZQ, automatic contrast medium injectors are cleared for the power injection of iodinated contrast agents during CT, angiography, and MRI examinations.
These programmable devices deliver precise volumes of contrast at controlled flow rates and pressures, ensuring consistent vascular enhancement and image quality. They are used in CT angiography, coronary angiography, and enhanced MRI protocols.
IZQ devices are Class II medical devices, regulated under 21 CFR 870.1650 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Ulrich GmbH & Co. KG.
List of Injector, Contrast Medium, Automatic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Injector, Contrast Medium, Automatic devices (product code IZQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →