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 Carestream Health, Inc..
List of System, X-ray, Stationary devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, X-ray, Stationary devices (product code KPR). 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 →