FDA Product Code OEB: Lung Computed Tomography System, Computer-aided Detection
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.
Leading manufacturers include Siemens Healthcare GmbH, Coreline Soft Co., Ltd. and Siemens AG Medical Solutions.
20
Total
20
Cleared
142d
Avg days
2003
Since
Growing category -
4 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
254d
recently vs 115d historically
FDA 510(k) Cleared Lung Computed Tomography System, Computer-aided Detection Devices (Product Code OEB)
20 devices
Cleared
May 27, 2026
Synapse Lung Nodule AI
Fujifilm Corporation
Radiology
160d
Cleared
Dec 03, 2025
AVIEW Lung Nodule CAD
Coreline Soft Co., Ltd.
Radiology
229d
Cleared
May 16, 2025
InferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.
Radiology
443d
Cleared
Mar 27, 2025
V5med Lung AI
V5med, Inc.
Radiology
184d
Cleared
Jul 19, 2023
syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH
Radiology
86d
Cleared
Feb 24, 2023
AVIEW Lung Nodule CAD
Coreline Soft Co., Ltd.
Radiology
267d
Cleared
Dec 05, 2022
ClearRead CT
Riverain Technologies, Inc.
Radiology
185d
Cleared
Mar 31, 2021
syngo.CT Lung CAD
Siemens Healthcare GmbH
Radiology
146d
Cleared
Feb 23, 2021
Veolity
Mevis Medical Solutions AG
Radiology
263d
Cleared
Jul 02, 2020
InferRead Lung CT.AI
Beijing Infervision Technology Co., Ltd.
Radiology
267d
Cleared
Mar 09, 2020
syngo.CT Lung CAD
Siemens Medi Cal Solutions, Inc.
Radiology
109d
Cleared
Sep 09, 2016
ClearRead CT
Riverain Technologies, LLC
Radiology
134d
Cleared
May 12, 2015
syngo.CT Lung CAD
Siemens AG Medical Solutions
Radiology
187d
Cleared
Dec 21, 2007
IMAGECHECKER CT CAD SOFTWARE SYSTEM
Hologic, Inc.
Radiology
25d
Cleared
Oct 18, 2006
SYNGO LUNG CAD
Siemens Medical Solutions USA, Inc.
Radiology
6d
Cleared
Nov 18, 2004
ADVANCED LUNG ANALYSIS II
GE Medical Systems
Radiology
49d
Cleared
Jul 22, 2004
LUNG CAR 1.1
Medicsight
Radiology
16d
Cleared
Jun 08, 2004
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
R2 Technology, Inc.
Radiology
14d
Cleared
Nov 06, 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Siemens AG Medical Solutions
Radiology
15d
About Product Code OEB - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code OEB since 2003, with 20 receiving FDA clearance (average review time: 142 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OEB Product Code
Recent submissions under OEB have taken an average of 254 days to reach a decision - up from 115 days historically. Manufacturers should account for longer review timelines in current project planning.
OEB devices are reviewed by the Radiology panel. Browse all Radiology devices →