syngo.via MI Workflows, syngo MBF
K201195Siemens Medical Solutions USA, Inc. · cleared 2020-11-18 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel.”
source quote (p.6)
“syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods. syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. 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 sites 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. The modifications to syngo.via MI Workflows and syngo MBF (within MI Cardiology) software (K191309 and K110494) include the following new features: Auto Lung 3D, Dynamic Summing, Automatic Layouts, Auto Ranges, Scanner Data Support for Organ Processing, Usability Improvements, Normalization by Rate-Pressure Product (syngo MBF), Cardiac Masking, Cardiac Auto Ranges, Usability Improvements, Updates / redeployment to third party software, Normals Database for FDOPA (Scenium).”
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
endpoints: functions work as designed; performance requirements and specifications have been met; all hazard mitigations have been fully implemented; All testing has met the predetermined acceptance values
standards: ISO 14971:2007 Second Edition, EN ISO 13485, IEC 62304 Edition 1.1 2015-06, NEMA PS 3.1 – 3.20 (2016), 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K211459 (decision 2021-06-10) 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:K211459
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).