510(k) K253058

Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Product Code IZL

K253058 is an FDA 510(k) premarket notification submitted by Shantou Institute of Ultrasonic Instruments Co., Ltd. for the device "Portable DR Imaging System". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Shantou Institute of Ultrasonic Instruments Co., Ltd. has at least 2 other 510(k) clearances on record.