OEB · Lung Computed Tomography System, Computer-Aided Detection
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | OEB |
|---|---|
| Device Name | Lung Computed Tomography System, Computer-Aided Detection |
| 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 (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | Dec 3, 2025 | SESE |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | May 16, 2025 | SESE |
| K242919 | V5med Lung AI | V5med, Inc. | Mar 27, 2025 | SESE |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | Jul 19, 2023 | SESE |
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | Feb 24, 2023 | SESE |
| K221612 | ClearRead CT | Riverain Technologies, Inc. | Dec 5, 2022 | SESE |
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | Mar 31, 2021 | SESE |
| K201501 | Veolity | MeVis Medical Solutions AG | Feb 23, 2021 | SESE |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | Jul 2, 2020 | SESE |
| K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | Mar 9, 2020 | SESE |
| K161201 | ClearRead CT | Riverain Technologies, LLC | Sep 9, 2016 | SESE |
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | May 12, 2015 | SESE |
| K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | Hologic, Inc. | Dec 21, 2007 | SESE |
| K063877 | SYNGO LUNG CAD | Siemens Medical Solutions USA, Inc. | Oct 18, 2006 | SESE |
| K042694 | ADVANCED LUNG ANALYSIS II | GE Medical Systems | Nov 18, 2004 | SESE |
| K041807 | LUNG CAR 1.1 | Medicsight | Jul 22, 2004 | SESE |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | R2 Technology, Inc. | Jun 8, 2004 | SESE |
| K033412 | MEDICLUNG, RELEASE 1 | Medicsight | Dec 30, 2003 | SESE |
| K033374 | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | Nov 6, 2003 | SESE |
Top Applicants
- Coreline Soft Co., Ltd. — 2 clearances
- Medicsight — 2 clearances
- Siemens AG Medical Solutions — 2 clearances
- Siemens Healthcare GmbH — 2 clearances
- Beijing Infervision Technology Co., Ltd. — 1 clearance
