FDA Product Code IZL: System, X-ray, Mobile
Under FDA product code IZL, mobile X-ray systems are cleared for bedside and point-of-care radiographic imaging.
These self-propelled or manually moved units bring diagnostic X-ray capability directly to patients who cannot be transported to a fixed radiology suite — including critically ill ICU patients, post-surgical patients, and those in emergency settings.
IZL devices are Class II medical devices, regulated under 21 CFR 892.1720 and reviewed by the FDA Radiology panel.
Leading manufacturers include Sedecal., Sa., Samsung Electronics Co., Ltd. and Shanghai United Imaging Healthcare Co., Ltd..
FDA 510(k) Cleared System, X-ray, Mobile Devices (Product Code IZL)
About Product Code IZL - Regulatory Context
510(k) Submission Activity
234 total 510(k) submissions under product code IZL since 1976, with 234 receiving FDA clearance (average review time: 86 days).
Submission volume has increased in recent years - 20 submissions in the last 24 months compared to 14 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under IZL have taken an average of 181 days to reach a decision - up from 77 days historically. Manufacturers should account for longer review timelines in current project planning.
IZL devices are reviewed by the Radiology panel. Browse all Radiology devices →