syngo.via MI Workflows; Scenium; syngo MBF

K251528

Siemens Medical Solutions USA, Inc. · cleared 2025-07-03 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“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 syngo.via MI Workflows applications are part of a larger syngo.via client/server system which is intended to be installed on common IT hardware. The hardware itself is not seen as part of the syngo.via MI Workflows medical device.”
AlgorithmAI/ML segmentation algorithm for lung lobe segmentation and PERCIST Liver Reference Region placement
source quote (p.9)
“The lung lobe segmentation algorithm was re-trained with additional data and is utilized within the Auto Lung 3D and Anatomy Segmentation features of the MI General workflow. This AI/ML segmentation algorithm is the same segmentation algorithm as utilized in the Anatomy Segmentation feature of the reference predicate device (K232000).”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=20 patients

endpoints: Dice coefficient (DSC)

Retrospective clinical

n=129 patients

endpoints: agreement with semi-automatic evaluation by expert readers; fewer intersections with suspicious uptake masks

Reported performance (3 observations)

diceas written: “Dice coefficient (DSC) for new organs”stated without value
source quote (p.10)
“For new organs, the average Dice coefficient per organ shall be greater than 0.8 or the average symmetric surface distance (ASSD) per organ less than 2 voxel of worst slice thickness, i.e. 10 mm.”
diceas written: “Dice coefficient (DSC) for unchanged organs”stated without value
source quote (p.10)
“For unchanged organs, the average Dice coefficient per organ shall be within +/-0.03 of the average Dice coefficient per organ of the predicate algorithm.”
diceas written: “Dice coefficient (DSC) for improved organs”stated without value
source quote (p.10)
“For improved organs, the average Dice coefficient per organ shall be greater or equal than the average Dice coefficient per organ of the predicate algorithm.”

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
0
drift signals on this device

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/K251528