AI devices with FDA product code QJU — Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Product code QJU (“Image Acquisition And/Or Optimization Guided By Artificial Intelligence” in openFDA) covers 8 devices on the FDA AI-enabled list, from 6 companies. Most are reviewed by the Radiology panel (8). The most recent decision was HeartFocus on June 3, 2026.
8AI devices
6Companies
2020First decision
2026-06-03Latest decision
Trend: devices per year
2020202320252026
Top companies
All 8 devices, newest first
- HeartFocusDeski · Radiology
- UltraSight GuidanceUltrasight , Ltd. · Radiology
- HeartFocus (V.1.1.1)Deski · Radiology
- Cardiac GuidanceCaption Health, Inc. · Radiology
- UltraSight AI GuidanceUltraSight Inc. · Radiology
- Caption GuidanceCaption Health · Radiology
- Caption GuidanceCaption Health · Radiology
- Caption GuidanceBay Labs, Inc. · Radiology