syngo.via MI WorkFlows, Scenium, syngo MBF
K211459Siemens Medical Solutions USA, Inc. · cleared 2021-06-10 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“syngo.via MI Workflows is a multi-modality post-processing software only medical device, which is intended to be installed on common IT hardware. This hardware must fulfill the defined requirements. The hardware itself is not seen as part of the medical device.”
source quote (p.6)
“Scenium consists of four workflows: Database Comparison, Striatal Analysis, Cortical Analysis, Subtraction syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The software is launched from the OpenApps Framework within the MI Cardiology workflow within syngo.Via MI Workflows. The application supports dynamic Rubidium – PET and dynamic Ammonia – PET images. The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, such as a database comparison workflow, for the Clinician to assess these results.”
source quote (p.8)
“Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Clinical Applications software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Clinical Applications software and external devices.”
Validation studies (1)
Bench
sample size not stated
standards: ISO 14971, EN ISO 13485, IEC 62304, IEC 62304 Edition 1.1 2015-06, NEMA PS 3.1 – 3.20 (2016), ISO, 14971:2019 Third Edition, IEC, 62366-1 Edition 1.0 2015, ISO 15223-1 Third Edition 2016
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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242275 (decision 2024-08-30) 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:K242275
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232000 (decision 2023-11-28) 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:K232000
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).