Product code

AI devices with FDA product code IYO — System, Imaging, Pulsed Echo, Ultrasonic

Product code IYO (“System, Imaging, Pulsed Echo, Ultrasonic” in openFDA) covers 12 devices on the FDA AI-enabled list, from 10 companies. Most are reviewed by the Radiology panel (12). The most recent decision was ARTHUR on June 18, 2026.

12AI devices

9Companies

2017First decision

2026-06-18Latest decision

Trend: devices per year

2017201820202023202420252026

AI devices with FDA product code IYO — System, Imaging, Pulsed Echo, Ultrasonic per year: 2017 1, 2018 1, 2020 1, 2023 2, 2024 3, 2025 1, 2026 3

Top companies

Sonic Incytes2
Butterfly Network, Inc.2
ROPCA ApS1
Edgecare, Inc.1
QT Imaging Holdings, Inc.1
Rivanna Medical, Inc.1
Verdure Imaging1
Edgecare Inc.1
EchoNous, Inc.1
Verathon Incorporated1

All 12 devices, newest first

ARTHURROPCA ApS · RadiologyK2601902026-06-18
EdgeFlow UW20Edgecare, Inc. · RadiologyK2522372026-04-17
QT Scanner 2000 Model AQT Imaging Holdings, Inc. · RadiologyK2538982026-03-04
Accuro 3SRivanna Medical, Inc. · RadiologyK2439372025-05-23
SpineUs SystemVerdure Imaging · RadiologyK2410292024-10-07
VelacurSonic Incytes · RadiologyK2339772024-09-04
EdgeFlow UH10Edgecare Inc. · RadiologyK2316772024-03-06
VelacurSonic Incytes · RadiologyK2232872023-04-20
Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · RadiologyK2200682023-03-31
Auto 3D Bladder Volume ToolButterfly Network, Inc. · RadiologyK2009802020-06-11
UscanEchoNous, Inc. · RadiologyK1815742018-07-10
BladderScan Prime PLUS SystemVerathon Incorporated · RadiologyK1723562017-09-15