FDA-cleared profile
Siemens Medical Solutions USA, Inc.
Authorized purpose: syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points, including PET or nuclear-medicine functional data and CT or MR anatomical data. The workflows support disease-management activities in oncology, cardiology, neurology, and organ function, and the images or results may aid radiotherapy treatment planning. The submission also describes Scenium neurology review and syngo MBF quantitative myocardial-blood-flow review for supported PET studies.
Product overview
Authorized purpose: syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points, including PET or nuclear-medicine functional data and CT or MR anatomical data. The workflows support disease-management activities in oncology, cardiology, neurology, and organ function, and the images or results may aid radiotherapy treatment planning. The submission also describes Scenium neurology review and syngo MBF quantitative myocardial-blood-flow review for supported PET studies.
Overview status: Source-reviewed overview
Clinical role: syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points, including PET or nuclear-medicine functional data and CT or MR anatomical data. The workflows support disease-management activities in oncology, cardiology, neurology, and organ function, and the images or results may aid radiotherapy treatment planning. The submission also describes Scenium neurology review and syngo MBF quantitative myocardial-blood-flow review for supported PET studies.
Evidence from the reviewed source record: K201195 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
This is a partial interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
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.
This is buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K201195 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared or authorized release includes them.
The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.
exact submission · checked 2026-09-04FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.
The exact FDA package describes the software as installed on the Siemens syngo.via platform and using supported molecular-imaging workflows; verify the installed release, DICOM routing, identity matching, archive, and local interface behavior.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. Radiopharmaceutical, scan, reconstruction, quantitative, anatomy, and patient limits are exact-configuration dependent; clinical decisions remain with qualified clinicians.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
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.
exact submission · checked 2026-09-04No exact-product price or reimbursement determination was promoted.
Monitor K201195 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: Radiopharmaceutical, scan, reconstruction, quantitative, anatomy, and patient limits are exact-configuration dependent; clinical decisions remain with qualified clinicians.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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.
Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K201195
FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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