QIH · Automated Radiological Image Processing Software
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | QIH |
|---|---|
| Device Name | Automated Radiological Image Processing Software |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Recent Cleared Devices (20 of 282)
Showing 20 most recent of 282 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | Apr 14, 2026 | SESE |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | Apr 10, 2026 | SESE |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | Apr 10, 2026 | SESE |
| K252708 | Relu Cloud | Relu BV | Apr 10, 2026 | SESE |
| K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | Apr 1, 2026 | SESE |
| K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | Mar 30, 2026 | SESE |
| K253775 | SwiftMR | Airs Medical, Inc. | Mar 26, 2026 | SESE |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | Mar 17, 2026 | SESE |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | Mar 16, 2026 | SESE |
| K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Mar 13, 2026 | SESE |
| K253551 | VELYS Hip Navigation | Depuy Ireland UC | Mar 6, 2026 | SESE |
| K252538 | CEPHX3D | Orca Dental AI , Ltd. | Mar 5, 2026 | SESE |
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | Mar 2, 2026 | SESE |
| K253535 | Ligence Heart | Ligence Uab | Feb 27, 2026 | SESE |
| K260217 | AI Platform 2.2 (AIP002) | Exo Imaging | Feb 24, 2026 | SESE |
| K252084 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | Feb 11, 2026 | SESE |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | Feb 10, 2026 | SESE |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | Jan 29, 2026 | SESE |
| K252091 | Surgical Reality Viewer | Medicalvr B.V. | Jan 29, 2026 | SESE |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | Jan 22, 2026 | SESE |
Top Applicants
- Dia Imaging Analysis, Ltd. — 10 clearances
- Siemens Medical Solutions USA, Inc. — 10 clearances
- Clarius Mobile Health Corp. — 5 clearances
- Ischemaview, Inc. — 5 clearances
- Overjet, Inc. — 5 clearances
