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., Ge Hualun Medical Systems Co. , Ltd. and Siemens Medical Solutions.
FDA 510(k) Cleared System, X-ray, Stationary Devices (Product Code KPR)
About Product Code KPR - Regulatory Context
510(k) Submission Activity
355 total 510(k) submissions under product code KPR since 1976, with 355 receiving FDA clearance (average review time: 93 days).
Submission volume has remained relatively stable over the observed period, with 18 submissions in the last 24 months.
FDA Review Time
Recent submissions under KPR have taken an average of 163 days to reach a decision - up from 90 days historically. Manufacturers should account for longer review timelines in current project planning.
KPR devices are reviewed by the Radiology panel. Browse all Radiology devices →