FDA Product Code LLZ: System, Image Processing, Radiological

FDA product code LLZ covers radiological image processing systems.

These are software and hardware platforms that acquire, process, display, and archive medical images from modalities such as CT, MRI, X-ray, and ultrasound. They are used across radiology departments, surgical suites, and telemedicine platforms.

LLZ devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Totoku Electric Co., Ltd. and Barco N.V..