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 310)
Showing 20 most recent of 310 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | Jul 15, 2026 | SESE |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Jul 7, 2026 | SESE |
| K253969 | ADAS 3D | Adas3D Medical S.L. | Jun 29, 2026 | SESE |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | Jun 29, 2026 | SESE |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Jun 25, 2026 | SESE |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | Jun 22, 2026 | SESE |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | Jun 18, 2026 | SESE |
| K260300 | WatchMate Software | Anumana, Inc. | Jun 15, 2026 | SESE |
| K253690 | LungMaps | Siemens Healthineers AG | Jun 15, 2026 | SESE |
| K253172 | MediAI-OA | Crescom Co., Ltd. | Jun 15, 2026 | SESE |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | Jun 12, 2026 | SESE |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Jun 11, 2026 | SESE |
| 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 |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 12 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
