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 Ewoosoft Co., Ltd., Siemens Healthcare GmbH and Mim Software, Inc..
List of System, Image Processing, Radiological devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Image Processing, Radiological devices (product code LLZ). 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 Radiology FDA review panel. Browse all Radiology devices →