Lung Computed Tomography System, Computer-Aided Detection
The Computer-Aided Detection Lung Computed Tomography System (product code OEB) is a radiology device that assists radiologists in reviewing multi-slice computed tomography (MSCT) chest exams by highlighting potential pulmonary nodules that warrant further radiologist review. It is a second-read aid and does not provide a diagnosis independently; a computer-aided diagnosis version falls under Class 3 (product code NRR). This device is FDA Class 2 under regulation 892.2050 in the Radiology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEB
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K254075 | Synapse Lung Nodule AI | May 27, 2026 | Substantially Equivalent | Fujifilm Corporation |
| K251203 | AVIEW Lung Nodule CAD | Dec 03, 2025 | Substantially Equivalent | Coreline Soft Co., Ltd. |
| K240554 | InferRead Lung CT.AI | May 16, 2025 | Substantially Equivalent | Infervision Medical Technology Co., Ltd. |
| K242919 | V5med Lung AI | Mar 27, 2025 | Substantially Equivalent | V5med, Inc. |
| K231157 | syngo.CT Lung CAD (Version VD30) | Jul 19, 2023 | Substantially Equivalent | Siemens Healthcare GmbH |
| K221592 | AVIEW Lung Nodule CAD | Feb 24, 2023 | Substantially Equivalent | Coreline Soft Co., Ltd. |
| K221612 | ClearRead CT | Dec 05, 2022 | Substantially Equivalent | Riverain Technologies, Inc. |
| K203258 | syngo.CT Lung CAD | Mar 31, 2021 | Substantially Equivalent | Siemens Healthcare GmbH |
| K201501 | Veolity | Feb 23, 2021 | Substantially Equivalent | MeVis Medical Solutions AG |
| K192880 | InferRead Lung CT.AI | Jul 02, 2020 | Substantially Equivalent | Beijing Infervision Technology Co., Ltd. |
| K193216 | syngo.CT Lung CAD | Mar 09, 2020 | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. |
| K161201 | ClearRead CT | Sep 09, 2016 | Substantially Equivalent | Riverain Technologies, LLC |
| K143196 | syngo.CT Lung CAD | May 12, 2015 | Substantially Equivalent | Siemens AG Medical Solutions |
| K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | Dec 21, 2007 | Substantially Equivalent | Hologic, Inc. |
| K063877 | SYNGO LUNG CAD | Oct 18, 2006 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K042694 | ADVANCED LUNG ANALYSIS II | Nov 18, 2004 | Substantially Equivalent | GE Medical Systems |
| K041807 | LUNG CAR 1.1 | Jul 22, 2004 | Substantially Equivalent | Medicsight |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | Jun 08, 2004 | Substantially Equivalent | R2 Technology, Inc. |
| K033412 | MEDICLUNG, RELEASE 1 | Dec 30, 2003 | Substantially Equivalent | Medicsight |
| K033374 | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Nov 06, 2003 | Substantially Equivalent | Siemens AG Medical Solutions |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.