FDA Product Code QIH: Automated Radiological Image Processing Software

As radiology departments face growing imaging volumes, automated analysis tools have become essential. FDA product code QIH covers automated radiological image processing software.

These AI-powered and algorithmic systems automatically analyze, segment, measure, or triage medical images from CT, MRI, X-ray, and other modalities to support radiologist workflow and clinical decision-making.

QIH devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Dia Imaging Analysis, Ltd. and Shanghai United Imaging Healthcare Co., Ltd..