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..