Product code

AI devices with FDA product code QIH — Automated Radiological Image Processing Software

Product code QIH (“Automated Radiological Image Processing Software” in openFDA) covers 305 devices on the FDA AI-enabled list, from 209 companies. Most are reviewed by the Radiology panel (305). The most recent decision was Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) on June 29, 2026.

305AI devices
180Companies
2019First decision
2026-06-29Latest decision

Trend: devices per year

2019: 22020: 112021: 192022: 252023: 442024: 632025: 932026: 48
20192020202120222023202420252026
AI devices with FDA product code QIH — Automated Radiological Image Processing Software per year: 2019 2, 2020 11, 2021 19, 2022 25, 2023 44, 2024 63, 2025 93, 2026 48

All 305 devices, newest first

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