syngo.CT Lung CAD (Version VD30)

K231157

Siemens Healthcare GmbH · cleared 2023-07-19 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The software device is an algorithm which does not have its own user interface component for displaying of CAD marks.”
AlgorithmConvolutional Neural Networks (CNN)
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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=712 cases · 3 site(s)

endpoints: the sensitivity of VD30 in solid-only mode is not inferior to VD20 in standard mode.; the mean number of false positives per subject is significantly lower with VD30 in solid-only mode; 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 and 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 (1 observation)

sensitivityas written: “lesion-level sensitivity”stated without value
source quote (p.15)
“showing that the sensitivity and mean number of FPs/subject of VD30 in standard mode are not inferior to VD20 in standard mode.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K231157