syngo.via MI Workflows; Scenium; syngo MBF

K242275

Siemens Medical Solutions USA, Inc. · cleared 2024-08-30 · 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. The hardware itself is not seen as part of the syngo.via MI Workflows medical device.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: The testing supports that all software specifications have met the acceptance criteria.; Verification and validation testing substantiates all requirement and functional specifications, including specifications related to device hazards, and supports the claim of substantial equivalence.

standards: PS 3.1-3.20 2022d, 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, 14971 Third Edition 2019-12, 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, 15223-1 Fourth edition 2021-07, 20417 First edition 2021-04 Corrected version 2021-12

Retrospective clinical

n=162 patients

endpoints: ROC analysis yielded excellent agreement with visual-based classification with an area under the ROC curve of 0.9872, and a corresponding optimal CL cut-off value of 26 (sensitivity 92.0%, specificity 96.3%)

Reported performance (3 observations)

sensitivity0.92
source quote (p.8)
“ROC analysis yielded excellent agreement with visual-based classification with an area under the ROC curve of 0.9872, and a corresponding optimal CL cut-off value of 26 (sensitivity 92.0%, specificity 96.3%)”
specificity0.963
source quote (p.8)
“ROC analysis yielded excellent agreement with visual-based classification with an area under the ROC curve of 0.9872, and a corresponding optimal CL cut-off value of 26 (sensitivity 92.0%, specificity 96.3%)”
aurocas written: “auc”0.9872
source quote (p.8)
“The ROC analysis yielded excellent agreement with visual-based classification with an area under the ROC curve of 0.9872, and a corresponding optimal CL cut-off value of 26 (sensitivity 92.0%, specificity 96.3%)”

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
1
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

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/K242275