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.
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 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 Medical 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 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.