syngo.via MI WorkFlows, Scenium, syngo MBF

K211459

Siemens Medical Solutions USA, Inc. · cleared 2021-06-10 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmThe device includes workflows for Database Comparison, Striatal Analysis, Cortical Analysis, and Subtraction, and provides tools for visualization, assessment, and quantification of medical images, including quantitative blood flow measurements of PET images.
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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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; hazard mitigations have been fully implemented; all testing has met the predetermined acceptance values; Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing

standards: ISO 14971, EN ISO 13485, IEC 62304, 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K211459