syngo.via MI Workflows; Scenium; syngo MBF

K232000

Siemens Medical Solutions USA, Inc. · cleared 2023-11-28 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmDeep Image-to-Image Network
source quote (p.8)
“The organ segmentation consists of a region of interest detection based on anatomical landmarks, followed by a Deep Image-to-Image Network performing the actual segmentation step.”
Adaptive (vs locked)No
source quote (p.8)
“The algorithm utilized is the same algorithm originally cleared within syngo.via RT Image Suite (K201444) and carried into the reference predicate device (syngo.via RT Image Suite, K220783).”
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: DICE coefficient; average symmetric surface distance (ASSD)

standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 - 3.20 2022d, Medical Device Software -Software Life Cycle Processes; 62304:2006 (1st Edition)/A1:2016, Medical devices - Application of risk management to medical devices; 14971 Third Edition 2019-12, Medical devices - Part 1: Application of usability engineering to medical devices 62366-1:2015+AMD1:2020, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements ISO 15223-1 Fourth edition 2021-07

Bench

n=700 images

endpoints: good correlations and agreement

standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 - 3.20 2022d, Medical Device Software -Software Life Cycle Processes; 62304:2006 (1st Edition)/A1:2016, Medical devices - Application of risk management to medical devices; 14971 Third Edition 2019-12, Medical devices - Part 1: Application of usability engineering to medical devices 62366-1:2015+AMD1:2020, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements ISO 15223-1 Fourth edition 2021-07

Reported performance (1 observation)

diceas written: “DICE coefficient”stated without value
source quote (p.8)
“All organs met criteria for either the average DICE coefficient or the ASSD.”

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
2
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

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/K232000