510(k) K242499

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) by Shenzhen Sontu Medical Imaging Equipment Co., Ltd. — Product Code KPR

K242499 is an FDA 510(k) premarket notification submitted by Shenzhen Sontu Medical Imaging Equipment Co., Ltd. for the device "Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))". The FDA issued a decision of Substantially Equivalent on January 6, 2025. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680.