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 and Imaxeon Pty, Ltd..
FDA 510(k) Cleared Injector, Contrast Medium, Automatic Devices (Product Code IZQ)
About Product Code IZQ - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code IZQ since 1976, with 22 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under IZQ have taken an average of 107 days to reach a decision - down from 155 days historically, suggesting improved FDA processing for this classification.
IZQ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →