Radiology AI Directory

FDA-cleared profile

syngo.via MI Workflows; Scenium; syngo MBF

Siemens Medical Solutions USA, Inc.

Authorized purpose: syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for oncology, cardiology, neurology, organ function, and selected radiation-planning support.

Oncology quantificationQuantification and segmentationNuclear medicine
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for oncology, cardiology, neurology, organ function, and selected radiation-planning support.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for oncology, cardiology, neurology, organ function, and selected radiation-planning support.

Evidence takeaway

Evidence from the reviewed source record: FDA materials describe verification of the release-specific Auto Lung 3D, V/Q, PET/SPECT masking, Deauville, liver-reference, CT oncology, lung CAD, and related workflow changes. Public family materials support implementation context but not universal performance across modules.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for oncology, cardiology, neurology, organ function, and selected radiation-planning support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.

Intended users
Radiologists, reading physicians, nuclear-medicine physicians, and nuclear-medicine technologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospital and outpatient molecular-imaging reading and processing environments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Client-server multimodality molecular-imaging review, quantification, comparison, and application-specific analysis.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
DICOM PET, SPECT, nuclear-medicine, CT, and MR studies imported automatically or from external media.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Displayed and processed images, quantitative measurements, comparisons, reports, and application-specific results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Function availability differs among MI Workflows VC10, Scenium VE70, and MBF VB30. Confirm licensing, modality, tracer, scanner, reference-region, harmonization, and radiation-planning scope for the exact installation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K251528
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
PET/SPECT/Nuclear Medicine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-07-03
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM client-server workflow with automatic network import and manual external-media import.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Software-only client-server applications on compatible general-purpose IT hardware.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only radiologists, reading physicians, nuclear-medicine physicians, and nuclear-medicine technologists. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: Function availability differs among MI Workflows VC10, Scenium VE70, and MBF VB30. Confirm licensing, modality, tracer, scanner, reference-region, harmonization, and radiation-planning scope for the exact installation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K251528 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM client-server workflow with automatic network import and manual external-media import.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Function availability differs among MI Workflows VC10, Scenium VE70, and MBF VB30. Confirm licensing, modality, tracer, scanner, reference-region, harmonization, and radiation-planning scope for the exact installation.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: Function availability differs among MI Workflows VC10, Scenium VE70, and MBF VB30. Confirm licensing, modality, tracer, scanner, reference-region, harmonization, and radiation-planning scope for the exact installation.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA materials describe verification of the release-specific Auto Lung 3D, V/Q, PET/SPECT masking, Deauville, liver-reference, CT oncology, lung CAD, and related workflow changes. Public family materials support implementation context but not universal performance across modules.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K251528 FDA performance package for syngo.via MI Workflows; Scenium; syngo MBF

  • DesignManufacturer software verification and application-specific validation across molecular-imaging viewing, processing, quantification, and analysis functions
  • PopulationRepresentative PET, SPECT, nuclear-medicine, CT, and MR datasets for oncology, cardiology, neurology, and organ-function workflows
  • Scopeexact submission
  • Tested versionsyngo.via MI Workflows VC10, Scenium VE70, and syngo MBF VB30
  • IndependenceSponsor or vendor study

K251528

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the device within the applicable imaging or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K251528 by exact submission identifier.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
11Source classes checked
18Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads

Eighteen PubMed records and two trial records were screened. Some mention Siemens or Scenium analysis, but none identifies the exact syngo.via MI Workflows, Scenium, or syngo MBF release configuration cleared in K251528. No evidence was promoted, and all 20 candidates remain quarantined. The current discovery snapshot contains 18 PubMed and 2 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, fda decision material, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K251528: syngo.via MI Workflows; Scenium; syngo MBF

    U.S. Food and Drug Administration - Published 2025-07-03 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. syngo.via molecular imaging reading software

    Siemens Healthineers - Accessed 2026-09-03

    Scope: productFamily, workflowRole, integration, deployment, implementationCapabilities, currentCommercialContext

Research history

  1. K251528 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K232712

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-10-03
Oncology quantificationDetection and CADeQuantification and segmentation
FDA-cleared K223325

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-03-10
Oncology quantificationDetection and CADeQuantification and segmentation
FDA-cleared K251153

Aurora

GE Medical Systems Israel

Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance,...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-06-12
Quantification and segmentationNuclear medicine