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 are medical diagnostic post-processing applications for viewing, manipulation, quantification, analysis, and comparison of PET or nuclear-medicine functional data with CT or MR anatomical data across timepoints, supporting disease management and radiotherapy treatment planning by trained healthcare professionals.

Radiotherapy planningQuantification 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 are medical diagnostic post-processing applications for viewing, manipulation, quantification, analysis, and comparison of PET or nuclear-medicine functional data with CT or MR anatomical data across timepoints, supporting disease management and radiotherapy treatment planning by trained healthcare professionals.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: syngo.via MI Workflows, Scenium, and syngo MBF are medical diagnostic post-processing applications for viewing, manipulation, quantification, analysis, and comparison of PET or nuclear-medicine functional data with CT or MR anatomical data across timepoints, supporting disease management and radiotherapy treatment planning by trained healthcare professionals.

Evidence takeaway

Evidence from the reviewed source record: The K242275 FDA decision summary describes the cleared syngo.via MI Workflows, Scenium, and syngo MBF functions, supported PET/NM and CT/MR inputs, DICOM workflow, SUV harmonization, and software verification and validation. The submitted package does not establish a universal clinical sensitivity or specificity claim; the literature and registry candidates remain quarantined until exact-version linkage is proven.

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 are medical diagnostic post-processing applications for viewing, manipulation, quantification, analysis, and comparison of PET or nuclear-medicine functional data with CT or MR anatomical data across timepoints, supporting disease management and radiotherapy treatment planning by trained healthcare professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Qualified nuclear medicine physicians, radiologists, and trained imaging analysts.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Molecular-imaging departments or validated research workflows using supported DICOM PET/CT examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
PET/CT visualization, segmentation, quantification, quality control, and structured reporting support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Supported DICOM PET/CT studies, radiopharmaceutical metadata, and user-confirmed regions of interest.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Visualizations, segmentations, measurements, quantitative disease-burden results, and reports for professional confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.
  • 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
K242275
  • 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
2024-08-30
  • 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 upload or network transfer to the analysis platform and return of reviewed results or reports; validate patient matching, study selection, permissions, report signing, and PACS or archive transfer.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K242275; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Release-specific workstation, server, or cloud web platform with supported DICOM and account configuration.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K242275; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

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

Training and support
Only qualified nuclear medicine physicians, radiologists, and trained imaging analysts should operate or interpret the product. 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, model, and algorithm 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 these product-specific limits: Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K242275; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K242275 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 upload or network transfer to the analysis platform and return of reviewed results or reports; validate patient matching, study selection, permissions, report signing, and PACS or archive transfer.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSourceSource

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. Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.

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

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm 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 these product-specific limits: Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSourceSource

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
The K242275 FDA decision summary describes the cleared syngo.via MI Workflows, Scenium, and syngo MBF functions, supported PET/NM and CT/MR inputs, DICOM workflow, SUV harmonization, and software verification and validation. The submitted package does not establish a universal clinical sensitivity or specificity claim; the literature and registry candidates remain quarantined until exact-version linkage is proven.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
92.0%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Reported specificity
92.0%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

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

K242275 FDA performance package for syngo.via MI Workflows; Scenium; syngo MBF

  • DesignManufacturer software, DICOM, quantitative, usability, and verification and validation package for the cleared syngo.via MI Workflows, Scenium, and syngo MBF release
  • PopulationPET or nuclear-medicine functional datasets with CT or MR anatomical datasets for oncology, cardiology, neurology, organ-function, and radiotherapy-planning workflows
  • Scopeexact submission
  • Tested versionsyngo.via MI Workflows; Scenium; syngo MBF (K242275)
  • IndependenceSponsor or vendor study

K242275

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

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, 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 product within the applicable imaging, procedural, 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 or approval.

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 K242275 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

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
2026-09-20Last searched
26Fields reviewed
13Source classes checked
18Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 18 PubMed and 2 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 summary K242275: syngo.via MI Workflows; Scenium; syngo MBF

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

    Scope: purpose, modality, anatomy, intendedUsers, 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 for molecular imaging

    Siemens Healthineers - Accessed 2026-09-03

    Scope: productFamilyContext, workflowRole, implementationCapabilities

  8. syngo MBF operator manual

    Siemens Healthineers - Accessed 2026-09-03

    Scope: productFamilyContext, workflowRole, implementationCapabilities

  9. Metabolic topography of autoimmune non-paraneoplastic encephalitis.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. SPECT findings on neuropsychiatric symptoms caused by nitrous oxide abuse.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Brain fluorodeoxyglucose PET in adrenoleukodystrophy.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. Brain (18)F-FDG PET analysis via interval-valued reconstruction: proof of concept for Alzheimer's disease diagnosis.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Age-Specific (18)F-FDG Image Processing Pipelines and Analysis Are Essential for Individual Mapping of Seizure Foci in Pediatric Patients with Intractable Epilepsy.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. The Diagnostic Value of 18 F-FDG PET in Parkinson Disease Based on Voxel Analysis.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Metabolic assessment of cerebral palsy with normal clinical MRI using (18)F-FDG PET imaging: A preliminary report.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  16. Application of siemens SMART neuro attenuation correction in brain PET imaging.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  17. Brain metabolism in substance-induced psychosis and schizophrenia: a preliminary PET study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  18. Enhancing the clinical diagnosis of the acute and subacute phases of autoimmune encephalitis and predicting the risk factors: the potential advantages of 18F-FDG PET/CT.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  19. [Evaluation of 99mTc-ECD SPECT/CT brain imaging with scenium analysis in patients with generalized anxiety disorder].

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  20. The accuracy of hippocampal volumetry and glucose metabolism for the diagnosis of patients with suspected Alzheimer's disease, using automatic quantitative clinical tools.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  21. Reliability of semiquantitative ¹⁸F-FDG PET parameters derived from simultaneous brain PET/MRI: a feasibility study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  22. Residual Activity Correction in Quantitative Myocardial Perfusion (13)N-Ammonia PET Imaging: A Study in Post-MI Patients.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  23. Test-retest repeatability and software reproducibility of myocardial flow measurements using rest/adenosine stress Rubidium-82 PET/CT with and without motion correction in healthy young volunteers.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  24. Comparison of clinical tools for measurements of regional stress and rest myocardial blood flow assessed with 13N-ammonia PET/CT.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  25. Inter-Software Reproducibility of Quantitative Values of Myocardial Blood Flow and Coronary Flow Reserve Acquired by [(13)N]NH(3) MPI PET/CT and the Effect of Motion Correction Tools.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  26. Dependency of cardiac rubidium-82 imaging quantitative measures on age, gender, vascular territory, and software in a cardiovascular normal population.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  27. Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  28. The Monaco Initiative for Concussion in Motorsport Pilots

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K242275 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

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