Product code

AI devices with FDA product code QFM — Radiological Computer-Assisted Prioritization Software For Lesions

Product code QFM (“Radiological Computer-Assisted Prioritization Software For Lesions” in openFDA) covers 40 devices on the FDA AI-enabled list, from 32 companies. Most are reviewed by the Radiology panel (40). The most recent decision was MammoSightAI on May 4, 2026.

40AI devices
29Companies
2019First decision
2026-05-04Latest decision

Trend: devices per year

2019: 42020: 42021: 52022: 92023: 82024: 62025: 32026: 1
20192020202120222023202420252026
AI devices with FDA product code QFM — Radiological Computer-Assisted Prioritization Software For Lesions per year: 2019 4, 2020 4, 2021 5, 2022 9, 2023 8, 2024 6, 2025 3, 2026 1

All 40 devices, newest first