AI devices with FDA product code KPR — System, X-Ray, Stationary
Product code KPR (“System, X-Ray, Stationary” in openFDA) covers 6 devices on the FDA AI-enabled list, from 5 companies. Most are reviewed by the Radiology panel (6). The most recent decision was uDR Aurora CX on September 19, 2025.
6AI devices
5Companies
2014First decision
2025-09-19Latest decision
Trend: devices per year
201420242025
Top companies
All 6 devices, newest first
- uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Definium Tempo SelectGE Hualun Medical Systems Co., Ltd · Radiology
- YSIO X.preeSiemens Medical Solutions · Radiology
- Radiography 7300 CPhilips Medical Systems DMC GmbH · Radiology
- YSIO X.preeSiemens Medical Solutions · Radiology
- YSIO MAXSIEMENS MEDICAL SOLUTIONS USA, INC. · Radiology