Radiology AI Directory

FDA-cleared profile

NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

Authorized purpose: NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly does not support radiation-therapy planning.

CT/CTA 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: NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly does not support radiation-therapy planning.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly does not support radiation-therapy planning.

Evidence takeaway

Evidence from the reviewed source record: K233657 describes manufacturer image-quality, dose, spectral, reconstruction, safety, software, and workflow verification. Peer-reviewed photon-counting CT literature supplies technology-level clinical context but should remain separate from exact-release claims.

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
NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly does not support radiation-therapy planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Qualified CT technologists and physicians trained in diagnostic and interventional CT 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.

Care setting and population
Hospital and outpatient CT and interventional imaging departments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Photon-counting CT acquisition, reconstruction, spectral imaging, diagnostic review, and treatment or interventional imaging support.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
X-ray projection data acquired by the photon-counting detector using supported protocols.
  • 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.

Output and human action
Cross-sectional CT images, spectral or quantitative image sets, and examination information.
  • 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.

Limitations
NAEOTOM Alpha does not support radiation therapy planning. The CT system is not the principal means of guidance in invasive procedures; needle orientation, needle advance, and handling are under the physician's control.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet directly states the radiation-therapy-planning exclusion and invasive-procedure guidance limitation; the product-family literature caveat is not packet text.

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
K233657
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • 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.

Anatomy
Multi-region
  • 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.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-03-28
  • 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 CT workflow with advanced image objects; validate PACS, RIS, worklist, quantitative consistency, reconstruction, and downstream software support.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Installed photon-counting CT system with syngo CT VB10 and corresponding detector, reconstruction, siting, and service infrastructure.
  • 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 qualified ct technologists and physicians trained in diagnostic and interventional ct workflows. 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: K233657 explicitly does not support radiation-therapy planning, unlike K243523. The scanner is not the principal guidance method for invasive procedures, and product-family literature does not establish every exact-version outcome.
  • 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 K233657 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 CT workflow with advanced image objects; validate PACS, RIS, worklist, quantitative consistency, reconstruction, and downstream software support.

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. K233657 explicitly does not support radiation-therapy planning, unlike K243523. The scanner is not the principal guidance method for invasive procedures, and product-family literature does not establish every exact-version outcome.

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: K233657 explicitly does not support radiation-therapy planning, unlike K243523. The scanner is not the principal guidance method for invasive procedures, and product-family literature does not establish every exact-version outcome.

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
K233657 describes manufacturer image-quality, dose, spectral, reconstruction, safety, software, and workflow verification. Peer-reviewed photon-counting CT literature supplies technology-level clinical context but should remain separate from exact-release claims.
  • 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 dose-delivery 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 dose-delivery function. Use the task-specific endpoints and tested population reported below.

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

K233657 FDA performance package for NAEOTOM Alpha

  • DesignManufacturer bench, phantom, image-quality, dose, reconstruction, safety, software, and workflow validation
  • PopulationRepresentative head and body diagnostic, screening, treatment, and interventional CT protocols
  • Scopeexact submission
  • Tested versionNAEOTOM Alpha with syngo CT VB10
  • IndependenceSponsor or vendor study

K233657

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

Clinical photon-counting CT experience and applications

  • DesignPeer-reviewed clinical technology review and experience report
  • PopulationPatients imaged with clinical photon-counting CT systems
  • Scopeproduct family
  • Tested versionPhoton-counting CT technology and NAEOTOM product family
  • IndependenceIndependent study

PMID 37602816

Technology-level evidence; K233657 explicitly excludes radiation-therapy planning.

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 K233657 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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
12Source classes checked
20Screened PubMed leads
8Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 20 PubMed and 8 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 20 PubMed and 8 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, peer reviewed publication, reimbursement policy, 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 history

Source ledger

  1. FDA K233657: NAEOTOM Alpha

    U.S. Food and Drug Administration - Published 2024-03-28 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse

  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. NAEOTOM Alpha photon-counting CT family

    Siemens Healthineers - Accessed 2026-09-03

    Scope: productFamily, workflowRole, implementationCapabilities, currentCommercialContext

  8. Clinical photon-counting CT experience and applications

    Radiology - Accessed 2026-09-03

    Scope: limitations, evidenceSummary, evidenceStudy, monitoring

Research history

  1. K233657 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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