DICOM networking
Configurable DICOM send/receive on independent workstation or supported Siemens imaging hardware.
exact submission · checked 2026-09-05FDA-cleared profile
syngo Application Software
Siemens Medical Solutions USA, Inc.
Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
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.
- Intended users
- Physicians using image review and image-guided diagnosis, treatment planning or treatment control applications.
- Care setting and population
- Diagnostic review workstations and interventional environments using Siemens angiography, fluoroscopy or radiography systems.
- Workflow role
- Diagnostic and interventional image post-processing
- 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.
- 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.
- 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.
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
- Modality
- Radiological images; modality varies or is not specified in FDA list
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
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)
- Decision date
- 2026-04-29
- FDA status
- FDA-cleared
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.
- Deployment and data flow
- Independent Siemens-released PC/workstation hardware or installation on Siemens X-ray and angiography systems.
- Security and privacy
- Vendor documentation pending
Submission cybersecurity testing is not a current site-specific security certification, patch-support contract or network assessment.
- Training and support
- Vendor documentation pending
Role-specific VE51A option training and site acceptance materials were not established.
- Monitoring and change control
- Vendor documentation pending
Post-installation performance monitoring and remote-service responsibilities require confirmation.
Current DynaCT option context
Vendor describes Bone Removal for adult thorax, abdomen and pelvis and MORE for motion-artifact reduction.
product family · checked 2026-09-05Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- 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.
- Reported sensitivity
- Not established in reviewed sources
No comparable product-wide sensitivity is established by the option-specific processing tests.
- Reported specificity
- Not established in reviewed sources
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
Standalone segmentation comparison and separate clinical reader evaluation · 180 reference-mask cases: 60 each thorax, abdomen and pelvis; separate 370 US/European datasets for reader evaluation
exact submission · Tested version: syngo Application Software VE51A, DynaCT Bone Removal · n=180 · Sponsor or vendor studyK254184
Sample size denotes reference-mask cohort only; reader cohort is not added to it as a unique patient total.
K254184 DynaCT MORE image-quality comparison
Retrospective comparative image-quality and diagnostic-utility reader assessment · 40 image datasets assessed by two readers
exact submission · Tested version: syngo Application Software VE51A, DynaCT MORE · n=40 · Sponsor or vendor studyK254184
SPINNERS
Prospective multicenter non-inferiority comparison of sine-spin flat-detector CT with multidetector CT · Adults with suspected ischemic or hemorrhagic stroke and feasible noncontrast syngo DynaCT Sine Spin within four hours of reference CT
product family · Tested version: syngo DynaCT Sine Spin; no VE51A linkage established · Sponsor or vendor studyNCT05458908
University Hospital Basel sponsor with Siemens Healthineers collaborator. Registry design context only; no trial result or exact-release diagnostic performance promoted.
Economics and lifecycle
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
VE51A hardware, upgrade and individual-option prices were not established from reviewed sources; obtain an optionized quote.
- Reimbursement and coding
- Research pending
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
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
- Verify security and privacy controls: Submission cybersecurity testing is not a current site-specific security certification, patch-support contract or network assessment.
- Verify training: Role-specific VE51A option training and site acceptance materials were not established.
- Verify pricing and total cost: VE51A hardware, upgrade and individual-option prices were not established from reviewed sources; obtain an optionized quote.
- Verify reimbursement and coding relevance: No applicable payer policy was reviewed for the software or its individual interventional applications.
- Verify local validation and lifecycle monitoring: Post-installation performance monitoring and remote-service responsibilities require confirmation.
- Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
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
0Reviewed PubMed leads
1Reviewed 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
Source ledger
Sources accessed through 2026-09-05.
- syngo Application Software VE51A: K254184 clearance and summary U.S. Food and Drug Administration · 2026-09-05
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- syngo DynaCT applications Siemens Healthineers · 2026-09-05
- SPINNERS: prospective evaluation of noncontrast sine-spin flat-detector CT for intracranial hemorrhage ClinicalTrials.gov / University Hospital Basel · 2026-09-05
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