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 Shanghai United Imaging Healthcare Co., Ltd..

304

Total

304

Cleared

155d

Avg days

2019

Since

Growing category - 176 submissions in the last 2 years vs 88 in the prior period

Consistent review times: 148d avg (recent)

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

304 devices

1–24 of 304

1 2 3 4

Cleared Jun 25, 2026

syngo.CT Coronary Cockpit

K253786

Siemens Medical Solutions USA, Inc.

Keya Medical Technology Co., Ltd.

Radiology · 111d

Cleared May 29, 2026

OrthoGrid Hip AI® 4.0

K260077

OrthoGrid Systems, Inc.

Imeka Solutions, Inc.

Radiology · 29d

Cleared May 22, 2026

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

K260324

Canon Medical Informatics, Inc.

Smart Alfa Teknoloji San. Ve Tic. A.S.

UNiD™ Spine Analyzer (SW3002)

K261289

Medicrea International S.A.S. (Medtronic)

BeauBrain Healthcare, Inc.

Radiology · 127d

Cleared Apr 30, 2026

Synapse 3D Base Tools (V7.2)

syngo Application Software

K254184

Siemens Medical Solutions USA, Inc.

Shanghai United Imaging Healthcare Co., Ltd.

Critical Care Suite with Enteric Tube Positioning AI Algorithm

K253502

Ge Medical Systems, LLC

syngo Dynamics (VA41F)

K253689

Siemens Healthcare GmbH

Radiology · 140d

Cleared Apr 10, 2026

Overjet Iris Intelligent Imaging System

Smart Soft Healthcare AD

Philips Medical Systems Nederland B.V.

Radiology · 119d

1 2 3 4

About Product Code QIH - Regulatory Context

510(k) Submission Activity

304 total 510(k) submissions under product code QIH since 2019, with 304 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 176 submissions in the last 24 months compared to 88 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 148 days recently vs 165 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