syngo.CT Lung CAD (Version VD30)
K231157Siemens Healthcare GmbH · cleared 2023-07-19 · product code OEB · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.”
source quote (p.6)
“Specifically, both the predicate VD20 and the subject device VD30 share the same algorithm based on Convolutional Neural Networks (CNN) and the same basic architectural workflow.”
source quote (p.16)
“Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.”
Validation studies (1)
Retrospective clinical
n=712 cases
endpoints: demonstrating that the sensitivity of VD30 in solid-only mode is not inferior to VD20 in standard mode; demonstrating that the mean number of false positives per subject is significantly lower with VD30 in solid-only mode; demonstrating that the 2 CAD systems overlap in TPs and FPs; comparing the lesion-level sensitivity and mean number of FPs/subject of the 2 CAD systems, both in standard mode, for identifying any nodules; showing that the sensitivity and mean number of FPs/subject of VD30 in standard mode are not inferior to VD20 in standard mode
standards: ISO 14971:2019 Third Edition 2019-12, IEC 62304 Edition 1.1 2015-06 Consolidated Version, IEC 62366-1 Edition 1.0 2015-02
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).