QIH · Class II · 21 CFR 892.2050

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..

330

Total

330

Cleared

156d

Avg days

2019

Since

Growing category - 180 submissions in the last 2 years vs 100 in the prior period

Consistent review times: 152d avg (recent)

FDA 510(k) Cleared Automated Radiological Image Processing Software Devices (Product Code QIH)

330 devices

1–24 of 330

1 2 3 4

Cleared Sep 25, 2026

syngo.CT Brain Quantification

K260055

Siemens Medical Solutions USA, Inc.

Rapid Platform (R6.7)

EchoPAC Software Only / EchoPAC Plug-in (v211)

K261623

GE Medical Systems Ultrasound and Primary Care Diagnostics

Radiology · 124d

Cleared Sep 15, 2026

Artificial Intelligence Renal Assessment (AIRA) Version 1

K261677

Aramis Global AI Consultancies, LLC

Quicktome Software Suite

K261795

Omniscient Neurotechnology Pty, Ltd.

Argus Cognitive, Inc.

AI Planning Logic, Inc.

Hermes Medical Solutions AB

VELMENI for DENTISTS (V4D) 3D

1 2 3 4

About Product Code QIH - Regulatory Context

510(k) Submission Activity

330 total 510(k) submissions under product code QIH since 2019, with 330 receiving FDA clearance (average review time: 156 days).

Submission volume has increased in recent years - 180 submissions in the last 24 months compared to 100 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QIH Product Code

FDA review times for QIH submissions have been consistent, averaging 152 days recently vs 161 days historically.

QIH devices are reviewed by the Radiology panel. Browse all Radiology devices →

FDA Product Code QIH: Automated Radiological Image Processing Software

FDA 510(k) Cleared Automated Radiological Image Processing Software Devices (Product Code QIH)

About Product Code QIH - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - QIH Product Code

Related FDA 510(k) Regulatory Insights