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 298)
Showing 20 most recent of 298 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | Jun 4, 2026 | SESE |
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | May 29, 2026 | SESE |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | May 28, 2026 | SESE |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | May 22, 2026 | SESE |
| K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | May 21, 2026 | SESE |
| K254131 | BAC | DeepHealth, Inc. | May 21, 2026 | SESE |
| K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | May 15, 2026 | SESE |
| K261273 | Neurophet AQUA | Neurophet., Inc. | May 15, 2026 | SESE |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | May 15, 2026 | SESE |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | May 15, 2026 | SESE |
| K260032 | Morph | BeauBrain Healthcare, Inc. | May 13, 2026 | SESE |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | Apr 30, 2026 | SESE |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | Apr 29, 2026 | SESE |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | Apr 23, 2026 | SESE |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | Apr 22, 2026 | SESE |
| K252332 | Folliscan | Mim Fertility | Apr 20, 2026 | SESE |
| 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 |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 11 clearances
- Dia Imaging Analysis, Ltd. — 10 clearances
- Shanghai United Imaging Healthcare Co., Ltd. — 6 clearances
- Clarius Mobile Health Corp. — 5 clearances
- Ischemaview, Inc. — 5 clearances
