Syngo Dynamics (Version VA40F)

K222428

Siemens Medical Solutions USA, Inc. · cleared 2022-11-14 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“syngo Dynamics is a software only medical device which is used with common IT hardware.”

AlgorithmAI/ML algorithm that enable an optional semi-automated method (Auto EF) to calculate left ventricle ejection fraction using ultrasound images.

source quote (p.10)

“Comparing with the predicate, the subject device is supplied with AI/ML algorithm that enable an optional semi-automated method (Auto EF) to calculate left ventricle ejection fraction using ultrasound images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.11)

“Cybersecurity considerations related to syngo Dynamics are included within this submission. Siemens Healthineers conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.”

Validation studies (1)

Bench

n=150 cases · 3 site(s)

endpoints: Pearson's correlation coefficient r 0.800 between the biplane EF generated by Auto EF and the ground truth; 12 predetermined acceptance criteria

standards: NEMA PS 3.1 - 3.20 (2016), ISO IEC 10918-1 First edition 1994-02-15, IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, ISO 14971 Third Edition 2019-12, IEEE Std 3333.2.1-2015, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, IEC TR 80001-2-2 Edition 1.0 2012-07, IEC 82304-1 Edition 1.0 2016-10

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).