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 Ischemaview, Inc..
FDA 510(k) Cleared Automated Radiological Image Processing Software Devices (Product Code QIH)
About Product Code QIH - Regulatory Context
510(k) Submission Activity
286 total 510(k) submissions under product code QIH since 2019, with 286 receiving FDA clearance (average review time: 156 days).
Submission volume has increased in recent years - 167 submissions in the last 24 months compared to 80 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for QIH submissions have been consistent, averaging 148 days recently vs 168 days historically.
QIH devices are reviewed by the Radiology panel. Browse all Radiology devices →