Radiology AI Directory

FDA-cleared profile

syngo Application Software

Siemens Medical Solutions USA, Inc.

Authorized purpose: Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.

Radiological images; modality varies or is not specified in FDA list workflow
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: Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.

Evidence takeaway

Evidence from the reviewed source record: FDA testing includes 180 expert-reference bone-mask cases, a separate 370-dataset bone-removal reader evaluation and a 40-dataset DynaCT MORE comparison. These validate specific processing options, not one product-wide disease-detection endpoint.

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
Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Physicians using image review and image-guided diagnosis, treatment planning or treatment control applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Diagnostic review workstations and interventional environments using Siemens angiography, fluoroscopy or radiography systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Diagnostic and interventional image post-processing
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
Medical images and network DICOM data for review and post-processing; supported options include angiographic cone-beam CT processing and TrueFusion ultrasound fusion.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Processed images and application-specific guidance. VE51A changes include myScrew Path Assist, Embolization Guidance, TrueFusion, CleanEdge, DynaCT Bone Removal, DynaCT MORE, contour overlay and QuantWeb/3D interaction on ARTIS Touch.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Capabilities depend on the installed software option and supported Siemens hardware/system configuration; the general clearance does not make every option available on every host.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K254184
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Existing broad catalog category preserved: the software spans radiographic, fluoroscopic/angiographic and cone-beam CT applications, including ultrasound fusion; it is not solely a CT product.

Anatomy
N/A
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Existing unassigned catalog anatomy preserved because the general indication is multi-application. Individual modules address spine, cardiovascular, neurovascular, thorax, abdomen and pelvis; N/A does not mean no anatomic use.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-04-29
  • 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
Can be configured within a network to send and receive DICOM data, with syngo or Windows-based software options.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Independent Siemens-released PC/workstation hardware or installation on Siemens X-ray and angiography systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Submission cybersecurity testing is not a current site-specific security certification, patch-support contract or network assessment.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Role-specific VE51A option training and site acceptance materials were not established.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Post-installation performance monitoring and remote-service responsibilities require confirmation.

DICOM networking

Configurable DICOM send/receive on independent workstation or supported Siemens imaging hardware.

exact submission · checked 2026-09-05
Source

Current DynaCT option context

Vendor describes Bone Removal for adult thorax, abdomen and pelvis and MORE for motion-artifact reduction.

product family · checked 2026-09-05
Source

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 testing includes 180 expert-reference bone-mask cases, a separate 370-dataset bone-removal reader evaluation and a 40-dataset DynaCT MORE comparison. These validate specific processing options, not one product-wide disease-detection endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

No comparable product-wide sensitivity is established by the option-specific processing tests.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

No comparable product-wide specificity is established by the option-specific processing tests.

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

K254184 DynaCT Bone Removal validation

  • DesignStandalone segmentation comparison and separate clinical reader evaluation
  • Population180 reference-mask cases: 60 each thorax, abdomen and pelvis; separate 370 US/European datasets for reader evaluation
  • Scopeexact submission
  • Tested versionsyngo Application Software VE51A, DynaCT Bone Removal
  • Samplen=180
  • IndependenceSponsor or vendor study

K254184

Sample size denotes reference-mask cohort only; reader cohort is not added to it as a unique patient total.

Source

K254184 DynaCT MORE image-quality comparison

  • DesignRetrospective comparative image-quality and diagnostic-utility reader assessment
  • Population40 image datasets assessed by two readers
  • Scopeexact submission
  • Tested versionsyngo Application Software VE51A, DynaCT MORE
  • Samplen=40
  • IndependenceSponsor or vendor study

K254184

Source

SPINNERS

  • DesignProspective multicenter non-inferiority comparison of sine-spin flat-detector CT with multidetector CT
  • PopulationAdults with suspected ischemic or hemorrhagic stroke and feasible noncontrast syngo DynaCT Sine Spin within four hours of reference CT
  • Scopeproduct family
  • Tested versionsyngo DynaCT Sine Spin; no VE51A linkage established
  • IndependenceSponsor or vendor study

NCT05458908

University Hospital Basel sponsor with Siemens Healthineers collaborator. Registry design context only; no trial result or exact-release diagnostic performance promoted.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

VE51A hardware, upgrade and individual-option prices were not established from reviewed sources; obtain an optionized quote.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer policy was reviewed for the software or its individual interventional applications.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-06

Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

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
2026-09-05Last searched
12Fields reviewed
10Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

Stored trial metadata screened and indexed primary registry content reviewed. SPINNERS retained as family design context, not VE51A results. The current discovery snapshot contains 0 PubMed and 1 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, clinical trial registry, stored candidate metadata, 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. syngo Application Software VE51A: K254184 clearance and summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: clinicalUse, input, output, deployment, integration, evidenceStudies

  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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  6. syngo DynaCT applications

    Siemens Healthineers - Accessed 2026-09-05

    Scope: productFamilyContext, implementationCapabilities

  7. SPINNERS: prospective evaluation of noncontrast sine-spin flat-detector CT for intracranial hemorrhage

    ClinicalTrials.gov / University Hospital Basel - Accessed 2026-09-05

    Scope: evidenceStudies, productFamilyContext

Research history

  1. K254184 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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