Lung CT Computer-Aided Detection
Finds and measures nodules on a chest CT, and tracks whether they changed since last time.
One of the older families here, and it has aged into something more useful than it started as.
The original job was finding lung nodules on a CT. The valuable job turned out to be measuring them consistently and comparing them with the last scan. A nodule that has not changed in two years is a very different conversation from one that grew four millimetres.
Humans are reliably bad at eyeballing small volume change across two scans taken months apart. Software is reliably good at it. That is a fair trade.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- OEB
- FDA name for it
- Lung Computed Tomography System, Computer-Aided Detection
- Rule number
- 21 CFR 892.2050
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask how it handles prior scans from a different scanner or a different site. Comparison is the whole value and it is where these tools break.
- Ask which measurement standard it reports in, and whether that matches how your team already follows nodules.
- Ask about the false positive count per scan. On lung CT it is usually higher than people expect.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Coreline Soft Co., Ltd. | 2 |
| Siemens Healthcare GmbH | 2 |
| Siemens AG Medical Solutions | 2 |
| Medicsight | 2 |
| Fujifilm Corporation | 1 |
| Infervision Medical Technology Co., Ltd. | 1 |
| V5med, Inc. | 1 |
| Riverain Technologies, Inc. | 1 |
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Synapse Lung Nodule AI | Fujifilm Corporation | May 27, 2026 | K254075 |
| AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | December 3, 2025 | K251203 |
| InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | May 16, 2025 | K240554 |
| V5med Lung AI | V5med, Inc. | March 27, 2025 | K242919 |
| syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | July 19, 2023 | K231157 |
| AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | February 24, 2023 | K221592 |
| ClearRead CT | Riverain Technologies, Inc. | December 5, 2022 | K221612 |
| syngo.CT Lung CAD | Siemens Healthcare GmbH | March 31, 2021 | K203258 |
| Veolity | MeVis Medical Solutions AG | February 23, 2021 | K201501 |
| InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | July 2, 2020 | K192880 |
| syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | March 9, 2020 | K193216 |
| ClearRead CT | Riverain Technologies, LLC | September 9, 2016 | K161201 |
| syngo.CT Lung CAD | Siemens AG Medical Solutions | May 12, 2015 | K143196 |
| IMAGECHECKER CT CAD SOFTWARE SYSTEM | Hologic, Inc. | December 21, 2007 | K043617 |
| SYNGO LUNG CAD | Siemens Medical Solutions USA, Inc. | October 18, 2006 | K063877 |
| ADVANCED LUNG ANALYSIS II | GE Medical Systems | November 18, 2004 | K042694 |
| LUNG CAR 1.1 | Medicsight | July 22, 2004 | K041807 |
| IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | R2 Technology, Inc. | June 8, 2004 | K041380 |
| MEDICLUNG, RELEASE 1 | Medicsight | December 30, 2003 | K033412 |
| LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | November 6, 2003 | K033374 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.