AI devices with FDA product code SGH — Ultrasound Imaging For Vascular Access For Hemodialysis

Product code SGH (“Ultrasound Imaging For Vascular Access For Hemodialysis” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Radiology panel (1). The most recent decision was X9 Ultrasound System on October 17, 2025.