syngo Dynamics (Version VA41D)
K242551Siemens Healthcare GmbH · cleared 2025-04-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“syngo Dynamics is a software only medical device which is used with common IT hardware.”
source quote (p.11)
“The functionalities and technological characteristics of subject and predicate devices are fundamentally the same except for differences in AI/ML-enabled features. Comparing with the predicate, the Auto EF algorithm of the subject device is re-trained with more training data to enhance the performance of calculating left ventricle ejection fraction using ultrasound images.”
source quote (p.11)
“In addition, the Auto EF algorithms are locked before integrating into the syngo Dynamics system.”
source quote (p.13)
“Siemens Healthineers will make future algorithm improvements under a Predetermined Change Control Plans (PCCPs) for Auto EF functions. The PCCP specifies anticipated modifications to the device software.”
source quote (p.12)
“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)
Retrospective clinical
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; Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria
standards: NEMA PS 3.1 - 3.20 (2023e), 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
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).