syngo.CT Lung CAD
K193216Siemens Medical Solutions, Inc · cleared 2020-03-09 · product code OEB · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The syngo.CT Lung CAD VC30 device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest that may have been initially overlooked. The syngo.CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.”
source quote (p.6)
“the fundamental technology has been replaced by deep learning technology. Specifically, the predicate VC20 uses feature-based and Machine Learning whereas the current VC30 uses algorithms based on Convolutional Neural Networks.”
Validation studies (1)
Bench
sample size not stated
endpoints: standalone sensitivity; false positive rate; true positive marks consistency; false positive marks consistency
standards: ISO 14971 Second edition 2007-03-01, 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).