syngo.CT Lung CAD (Version VD30)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231157 FDA 510(k)
- FDA Product Code
- OEB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
syngo.CT Lung CAD (Version VD30) is a Computer-Aided Detection system for lung nodules in chest computed tomography (CT) scans. It functions as an automated analysis tool designed to identify and flag potentially suspicious lesions within lung tissue, aiding radiologists in the detection and evaluation of abnormalities.
This software-based device is intended for use in radiology settings and operates within the syngo.via platform. It is a Class 2 device (product code OEB) and has received FDA 510(k) clearance under the Traditional pathway. The system is non-sterile, reusable, and does not require MRI safety classification. No specific sterility or single-use designation is stated in the regulatory data.
Frequently asked questions
What is the primary purpose of the syngo.CT Lung CAD (Version VD30) in clinical practice?
The syngo.CT Lung CAD (Version VD30) is an automated Computer-Aided Detection (CAD) system specifically designed to analyze chest CT scans and identify potential lung nodules or suspicious lesions. It assists radiologists by flagging areas of concern, helping to improve the detection and evaluation of abnormalities in lung tissue during routine imaging.
How is the syngo.CT Lung CAD (Version VD30) supplied and what type of environment is it intended for?
The syngo.CT Lung CAD (Version VD30) is a software-based system that operates within the syngo.via platform, meaning it is not a physical device but rather a digital tool integrated into existing radiology workflows. It is intended for use in radiology settings where chest CT scans are performed, supporting radiologists in their analysis of lung imaging.
Is the syngo.CT Lung CAD (Version VD30) a single-use or reusable device, and what are its sterility requirements?
The syngo.CT Lung CAD (Version VD30) is explicitly described as a non-sterile, reusable software-based system. Since it is a digital tool rather than a physical implantable or invasive device, there are no sterility requirements or single-use constraints—it is designed for repeated use within the syngo.via platform.
What regulatory pathway was followed for FDA clearance of the syngo.CT Lung CAD (Version VD30), and what classification does it hold?
The syngo.CT Lung CAD (Version VD30) was cleared under the FDA 510(k) Traditional pathway and is classified as a Class 2 device with product code OEB. This classification aligns with its role as a Computer-Aided Detection system for lung nodules in CT imaging, which falls under the Radiology advisory committee’s purview.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: syngo.CT Lung CAD - Siemens Healthineers, K231157 - syngo.CT Lung CAD (Version VD30) | FDA 510 (k), syngo.CT Lung CAD (Version VD30) (K231157) — FDA 510 (k) | Innolitics, CT Lung CAD - Siemens Healthineers Academy
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231157 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K231157 24 fields · synced Oct 6, 2026