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..
FDA 510(k) Cleared System, Image Processing, Radiological Devices (Product Code LLZ)
About Product Code LLZ - Regulatory Context
510(k) Submission Activity
2263 total 510(k) submissions under product code LLZ since 1983, with 2263 receiving FDA clearance (average review time: 106 days).
Submission volume has declined in recent years - 111 submissions in the last 24 months compared to 154 in the prior period.
FDA Review Time
Recent submissions under LLZ have taken an average of 161 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
LLZ devices are reviewed by the Radiology panel. Browse all Radiology devices →