FDA Product Code KPR: System, X-ray, Stationary

FDA product code KPR covers stationary X-ray systems for fixed-installation diagnostic radiography.

These systems consist of a fixed X-ray tube, generator, and digital or analog image receptor used in radiology departments for routine chest, skeletal, and abdominal imaging. Modern stationary systems increasingly use flat panel digital detectors for immediate image capture and display.

KPR devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Shanghai United Imaging Healthcare Co., Ltd. and Ge Hualun Medical Systems Co. , Ltd..