Authorized purpose: The SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as an aid in diagnosis, treatment and radiation therapy planning, and diagnostic or therapeutic interventions; the systems may also be used for low-dose lung cancer screening in high-risk populations.
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: The SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as an aid in diagnosis, treatment and radiation therapy planning, and diagnostic or therapeutic interventions; the systems may also be used for low-dose lung cancer screening in high-risk populations.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: The SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as an aid in diagnosis, treatment and radiation therapy planning, and diagnostic or therapeutic interventions; the systems may also be used for low-dose lung cancer screening in high-risk populations.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Whole body Input: X-ray transmission data acquired on the listed SOMATOM go and SOMATOM X single-source CT scanner systems; supported options include three-dimensional camera data for patient positioning and external respiratory trigger signals for specified workflows.
Who uses it?Intended users: Trained and qualified users in professional healthcare facilities, including physicians, radiologists, and technologists; diagnosis or treatment requires appropriately qualified U.S. users.
What does the software produce?Output: Reconstructed cross-sectional CT images in DICOM format for qualified-user review and compatible optional post-processing applications; supported features include positioning, reconstruction, image-evaluation, and intervention workflow outputs depending on system configuration.
What is its most important limitation?Key limitation: The CT systems are not the principal means of guidance during invasive procedures, and needle orientation and advancement remain under physician control. Optional advanced-visualization applications require their own cleared standalone version, and feature availability varies across scanner models and configurations.
Clinical takeaway
Clinical role: The SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as an aid in diagnosis, treatment and radiation therapy planning, and diagnostic or therapeutic interventions; the systems may also be used for low-dose lung cancer screening in high-risk populations.
Evidence takeaway
Evidence from the reviewed source record: FDA-reviewed support consists of non-clinical integration, functional, image-quality, phantom, and bench testing for the listed CT platforms with syngo CT VB10. The 510(k) summary does not describe an independent clinical outcomes study.
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 SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as an aid in diagnosis, treatment and radiation therapy planning, and diagnostic or therapeutic interventions; the systems may also be used for low-dose lung cancer screening in high-risk populations.
FDA source
Exact FDA submission
Checked 2026-09-19
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
Trained and qualified users in professional healthcare facilities, including physicians, radiologists, and technologists; diagnosis or treatment requires appropriately qualified U.S. users.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
CT patient positioning and acquisition, image reconstruction, image evaluation, and optional post-processing support within diagnosis, treatment planning, radiation therapy planning, and intervention workflows.
X-ray transmission data acquired on the listed SOMATOM go and SOMATOM X single-source CT scanner systems; supported options include three-dimensional camera data for patient positioning and external respiratory trigger signals for specified workflows.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Reconstructed cross-sectional CT images in DICOM format for qualified-user review and compatible optional post-processing applications; supported features include positioning, reconstruction, image-evaluation, and intervention workflow outputs depending on system configuration.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The CT systems are not the principal means of guidance during invasive procedures, and needle orientation and advancement remain under physician control. Optional advanced-visualization applications require their own cleared standalone version, and feature availability varies across scanner models and configurations.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The exact device classification names the subject device as a Computed Tomography X-ray System. Controlled directory normalization: Computed Tomography X-ray System -> CT/CTA.
The exact technical-characteristics section identifies the scanner principle as a Whole body X-Ray Computed Tomography Scanner; no narrower anatomy is inferred.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The platform produces DICOM images and provides software interfaces for compatible optional post-processing applications, including previously cleared Siemens applications and other commercially distributed software.
FDA source
Exact FDA submission
Checked 2026-09-02
Confirm PACS routing, DICOM object support, interface versions, and each optional application's clearance and compatibility for the planned local configuration.
On-premises SOMATOM go or SOMATOM X scanner and computer platform running SOMARIS/10 syngo CT VB10, supplied ex-factory or as an optional upgrade for applicable existing systems.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Supported platforms and version
SOMATOM go.Up, go.Now, go.All, go.Top, go.Sim, go.Open Pro, X.cite, and X.ceed with SOMARIS/10 syngo CT VB10.
exact submission · checked 2026-09-02
Feature availability differs by scanner model; verify the exact purchased and installed configuration.
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-reviewed support consists of non-clinical integration, functional, image-quality, phantom, and bench testing for the listed CT platforms with syngo CT VB10. The 510(k) summary does not describe an independent clinical outcomes study.
EndpointCases in which the myNeedle Guide automatic needle-detection algorithm consistently detected the needle tip
PopulationA wide variety of CT scans used in manufacturer bench testing; sample size and clinical case composition were not reported in the 510(k) summary
Tested versionmyNeedle Guide with myNeedle Detection on supported K233650 systems with SOMARIS/10 syngo CT VB10
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 2026-08-13
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-08-31
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
FDA recall Z-1239-2026 affects syngo.CT Brain Quantification, Vessel Hyperdensities, and ASPECTS applications on certain SOMATOM X.ceed systems. The FDA record states that the applications had not received 510(k) clearance, directs sites to stop using them in patient care, and says Siemens would remove them. FDA lists the recall as open and classified.
FDA source
Exact product version
Checked 2026-09-04
Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.
Exact SOMATOM X.ceed application match. The finding applies to the named applications and affected installations, not every function of the scanner platform.
Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
21Fields reviewed
9Source classes checked
4Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 4 PubMed and 0 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 4 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 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 device recall, fda decision summary packet, 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 history6 sources - 3 history items
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