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 VATECH Co., Ltd..
List of System, X-ray, Mobile devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, X-ray, Mobile devices (product code IZL). 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 →