Product code

AI devices with FDA product code OWB — Interventional Fluoroscopic X-Ray System

Product code OWB (“Interventional Fluoroscopic X-Ray System” in openFDA) covers 15 devices on the FDA AI-enabled list, from 12 companies. Most are reviewed by the Radiology panel (15). The most recent decision was Intelligent NR on April 30, 2026.

15AI devices
12Companies
2016First decision
2026-04-30Latest decision

Trend: devices per year

2016: 12021: 32022: 12024: 12025: 52026: 4
201620212022202420252026
AI devices with FDA product code OWB — Interventional Fluoroscopic X-Ray System per year: 2016 1, 2021 3, 2022 1, 2024 1, 2025 5, 2026 4

Top companies

All 15 devices, newest first