AI devices with FDA product code JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Product code JAA (“System, X-Ray, Fluoroscopic, Image-Intensified” in openFDA) covers 4 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Radiology panel (4). The most recent decision was Soteria E-View on January 6, 2025.
4AI devices
3Companies
2018First decision
2025-01-06Latest decision
Trend: devices per year
2018201920232025
Top companies
All 4 devices, newest first
- Soteria E-ViewOmega Medical Imaging, LLC · Radiology
- XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · Radiology
- CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)Omega Medical Imaging, LLC · Radiology
- DR 800 with MUSICA DynamicAgfa HealthCare N.V. · Radiology