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., Ischemaview, Inc. and Shanghai United Imaging Healthcare Co., Ltd..
List of Automated Radiological Image Processing Software devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Automated Radiological Image Processing Software devices (product code QIH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →