Lung Computed Tomography System, Computer-Aided Detection
Regulation 892.2050
2510(k)s in 12 months (20 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 3 | 0 |
| Coreline Soft Co., Ltd. | 2 | 0 |
| Medicsight | 2 | 0 |
| Riverain Technologies, Inc. | 2 | 0 |
| Siemens Healthcare GmbH | 2 | 0 |
| Beijing Infervision Technology Co., Ltd. | 1 | 0 |
| Fujifilm Corporation | 1 | 0 |
| GE Medical Systems | 1 | 0 |
| Hologic, Inc. | 1 | 0 |
| Infervision Medical Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2026 | K254075 | Synapse Lung Nodule AI Fujifilm Corporation, JP | OEB |
| Dec 3, 2025 | K251203 | AVIEW Lung Nodule CAD Coreline Soft Co., Ltd., KR | OEB |
| May 16, 2025 | K240554 | InferRead Lung CT.AI Infervision Medical Technology Co., Ltd., CN | OEB |
| Mar 27, 2025 | K242919 | V5med Lung AI V5med, Inc., TW | OEB |
| Jul 19, 2023 | K231157 | syngo.CT Lung CAD (Version VD30) Siemens Healthcare GmbH, DE | OEB |
| Feb 24, 2023 | K221592 | AVIEW Lung Nodule CAD Coreline Soft Co., Ltd., KR | OEB |
| Dec 5, 2022 | K221612 | ClearRead CT Riverain Technologies, Inc. | OEB |
| Mar 31, 2021 | K203258 | syngo.CT Lung CAD Siemens Healthcare GmbH, DE | OEB |
| Feb 23, 2021 | K201501 | Veolity MeVis Medical Solutions AG, DE | OEB |
| Jul 2, 2020 | K192880 | InferRead Lung CT.AI Beijing Infervision Technology Co., Ltd., CN | OEB |
| Mar 9, 2020 | K193216 | syngo.CT Lung CAD Siemens Medi Cal Solutions, Inc. | OEB |
| Sep 9, 2016 | K161201 | ClearRead CT Riverain Technologies, LLC | OEB |
| May 12, 2015 | K143196 | syngo.CT Lung CAD Siemens AG Medical Solutions | OEB |
| Dec 21, 2007 | K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM Hologic, Inc. | OEB |
| Oct 18, 2006 | K063877 | SYNGO LUNG CAD Siemens Medical Solutions USA, Inc. | OEB |
| Nov 18, 2004 | K042694 | ADVANCED LUNG ANALYSIS II GE Medical Systems | OEB |
| Jul 22, 2004 | K041807 | LUNG CAR 1.1 Medicsight, GB | OEB |
| Jun 8, 2004 | K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR R2 Technology, Inc. | OEB |
| Dec 30, 2003 | K033412 | MEDICLUNG, RELEASE 1 Medicsight, GB | OEB |
| Nov 6, 2003 | K033374 | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Siemens AG Medical Solutions, DE | OEB |
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