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syngo.CT Lung CAD

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203258

by Siemens Healthcare GmbH

Identifiers

510(k) Number
K203258 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)

The syngo.CT Lung CAD is a Lung Computed Tomography System, Computer-Aided Detection (CAD) device, designed to assist radiologists in identifying and marking potentially suspicious lesions in chest CT datasets. It operates as an automated analysis tool, leveraging algorithmic processing to enhance detection accuracy for nodules or abnormalities within lung tissue, thereby supporting diagnostic workflows in radiology.

This device is integrated into the syngo.via platform, where processed results are displayed in the Findings Navigator for review. It is a Class 2 Radiology device with product code OEB, cleared under the FDA 510(k) Traditional pathway (K203258). The system is intended for single-use within a radiology setting, with no explicit sterility requirements stated, and operates without MRI safety constraints. No additional storage or regulatory authorisations beyond the FDA clearance are referenced.

Frequently asked questions

What is the primary purpose of the syngo.CT Lung CAD in a radiology workflow?

The syngo.CT Lung CAD is an automated computer-aided detection tool designed to assist radiologists by identifying and marking potential suspicious lesions or nodules in chest CT scans. It processes lung tissue data to highlight abnormalities, helping streamline diagnostic reviews within the syngo.via platform’s Findings Navigator.

Is the syngo.CT Lung CAD intended for repeated use in the same patient or a single session?

The device is specified for single-use within a radiology setting. While it doesn’t require sterility, it is not meant to be reused across multiple patients or sessions, aligning with standard practices for software-based diagnostic aids in imaging.

How is the syngo.CT Lung CAD integrated into the broader Siemens imaging ecosystem?

The syngo.CT Lung CAD operates as a module within the syngo.via platform, where processed results—such as marked lesions—are displayed in the Findings Navigator. This integration allows radiologists to review automated findings directly alongside their CT datasets, enhancing workflow efficiency.

Are there any special storage requirements for the syngo.CT Lung CAD beyond standard IT infrastructure?

No additional storage requirements beyond those needed for the syngo.via platform are referenced. The device relies on the platform’s existing infrastructure to process and display CT data, so standard IT compliance (e.g., data backup, network access) applies, but no proprietary storage solutions are required.

What regulatory pathway was followed for FDA clearance of the syngo.CT Lung CAD?

The device was cleared under the FDA’s Traditional 510(k) pathway (K203258), with a decision of ‘Substantially Equivalent’ to a predicate device. It falls under product code OEB and is classified as a Class 2 Radiology device, indicating it underwent a review by the Radiology (RA) Advisory Committee.

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, CT Lung CAD - Siemens Healthineers Academy, K203258 FDA 510(k) - syngo.CT Lung CAD | Siemens Healthcare GmbH, PDF July 19, 2023 Siemens Healthcare GmbH Abhineet Johri Regulatory Affairs ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (1)

  • FDA 510(k) K203258 24 fields · synced Oct 6, 2026