QKB · Radiological Image Processing Software For Radiation Therapy
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | QKB |
|---|---|
| Device Name | Radiological Image Processing Software For Radiation Therapy |
| 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 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | Apr 10, 2026 | SESE |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | Apr 10, 2026 | SESE |
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | Mar 27, 2026 | SESE |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | Mar 19, 2026 | SESE |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | Jan 28, 2026 | SESE |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | Jan 23, 2026 | SESE |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | Dec 5, 2025 | SESE |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | May 28, 2025 | SESE |
| K242925 | MR Contour DL | GE Healthcare | Apr 1, 2025 | SESE |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | Mar 27, 2025 | SESE |
| K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | Feb 24, 2025 | SESE |
| K250035 | Contour ProtégéAI+ | Mim Software, Inc. | Feb 3, 2025 | SESE |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | Dec 9, 2024 | SESE |
| K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | Oct 18, 2024 | SESE |
| K241837 | Limbus Contour | Limbus Ai, Inc. | Oct 9, 2024 | SESE |
| K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. | May 7, 2024 | SESE |
| K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | Apr 3, 2024 | SESE |
| K231855 | QOCA® image Smart RT Contouring System | Quanta Computer, Inc. | Feb 13, 2024 | SESE |
| K231765 | Contour ProtégéAI | Mim Software, Inc. | Nov 8, 2023 | SESE |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | Sep 25, 2023 | SESE |
Top Applicants
- Mim Software, Inc. — 7 clearances
- Radformation, Inc. — 5 clearances
- Vysioneer, Inc. — 3 clearances
- Manteia Technologies Co., Ltd. — 3 clearances
- Ever Fortune.Ai, Co., Ltd. — 3 clearances
