syngo.via MI Workflows; Scenium; syngo MBF
K242275Siemens Medical Solutions USA, Inc. · cleared 2024-08-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“syngo.via MI Workflows (including Scenium and syngo MBF applications) is a multi-modality post-processing software only medical device intended to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function.”
source quote (p.7)
“Centiloid scoring is implemented and intended to standardize brain PET Amyloid quantification across all three approved tracers below.¹”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: agreement and bias between syngo-Aẞ CL values and standard method; agreement between syngo-Aẞ and ADNI CL values
Retrospective clinical
n=162 patients
endpoints: agreement of Scenium Centiloid scale with visual reading; ROC analysis for agreement with visual-based classification
Reported performance (3 observations)
source quote (p.8)
“sensitivity 92.0%”
source quote (p.8)
“specificity 96.3%”
source quote (p.8)
“an area under the ROC curve of 0.9872”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251528 (decision 2025-07-03) from Siemens Medical Solutions USA, Inc. for a matching device line ("syngo.via MI Workflows; Scenium; syngo MBF") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251528
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).