Radiology AI Directory

FDA-cleared profile

syngo.via MI Workflows; Scenium; syngo MBF

Siemens Medical Solutions USA, Inc.

The applications support PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, analysis, longitudinal comparison, organ segmentation, tumor-burden assessment, tau analysis, myocardial blood-flow analysis, and selected radiotherapy-planning support.

Radiotherapy planningOncology 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.

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
The applications support PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, analysis, longitudinal comparison, organ segmentation, tumor-burden assessment, tau analysis, myocardial blood-flow analysis, and selected radiotherapy-planning support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Reading physicians, radiologists, nuclear-medicine technologists, and other appropriately trained healthcare professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospital and outpatient molecular-imaging reading environments using the syngo.via client/server platform.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Multimodality molecular-imaging post-processing and quantitative review for oncology, cardiology, neurology, organ function, and selected treatment-planning workflows.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
PET or nuclear-medicine functional data plus optional CT or MR anatomical datasets from one or more time points.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Reviewed visualizations, measurements, harmonized PET SUV values, organ and lesion analysis, tau SUVR values, and myocardial blood-flow results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Clinical testing was not conducted for K232000. Segmentation can be affected by scanner calibration, reconstruction, contrast protocol, dose, motion, anatomy, organ size, orientation, and user skill; all quantitative outputs require professional review.
  • 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
K232000
  • 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
2023-11-28
  • 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 transfers into a syngo.via server/client environment with configurable automatic import, manual media import, reporting, and storage; validate PET/SPECT/CT/MR objects, SUV harmonization, time points, output routing, and OpenApps launch behavior.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Software-only applications installed on common IT hardware as part of the syngo.via client/server system; exact licenses and supported platform versions must be mapped locally.
  • 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 reading physicians, radiologists, nuclear-medicine technologists, and other appropriately trained healthcare professionals. 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: Clinical testing was not conducted for K232000. Segmentation can be affected by scanner calibration, reconstruction, contrast protocol, dose, motion, anatomy, organ size, orientation, and user skill; all quantitative outputs require professional review.
  • 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 K232000 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 transfers into a syngo.via server/client environment with configurable automatic import, manual media import, reporting, and storage; validate PET/SPECT/CT/MR objects, SUV harmonization, time points, output routing, and OpenApps launch behavior.

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. Clinical testing was not conducted for K232000. Segmentation can be affected by scanner calibration, reconstruction, contrast protocol, dose, motion, anatomy, organ size, orientation, and user skill; all quantitative outputs require professional review.

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: Clinical testing was not conducted for K232000. Segmentation can be affected by scanner calibration, reconstruction, contrast protocol, dose, motion, anatomy, organ size, orientation, and user skill; all quantitative outputs require professional review.

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
K232000 reports software verification, quantitative organ-segmentation testing, and agreement testing for tau quantification. All organs met either Dice or average symmetric surface-distance criteria, and tau SUVR comparisons on more than 700 ADNI flortaucipir images showed good correlation and agreement with an MR-based method; no clinical study was performed.
  • 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 quantitative-biomarker 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 quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

Tau workflow comparison images

700 images

  • EndpointFlortaucipir SUVR agreement against an MR-based method
  • Populationsyngo.via MI Workflows; Scenium; syngo MBF
  • Tested versionsyngo.via MI Workflows VB80A, Scenium VE60, and syngo MBF VB30
Source

K232000 FDA performance package for syngo.via MI Workflows; Scenium; syngo MBF

  • DesignManufacturer nonclinical software verification plus organ-segmentation and tau-quantification agreement testing
  • PopulationRepresentative molecular-imaging datasets, including more than 700 ADNI flortaucipir PET images for the tau workflow
  • Scopeexact submission
  • Tested versionsyngo.via MI Workflows VB80A, Scenium VE60, and syngo MBF VB30
  • IndependenceSponsor or vendor study

K232000

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 K232000 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
24Fields reviewed
8Source classes checked
18Awaiting review PubMed leads
2Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 18 PubMed and 2 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, 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. K232000 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  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. K232000 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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