FDA-cleared profile
Siemens Medical Solutions USA, Inc.
NAEOTOM Alpha.Peak, Alpha, Alpha.Pro, and Alpha.Prime are photon-counting CT systems for diagnostic cross-sectional imaging, treatment and interventional support, low-dose lung-cancer screening under approved protocols, and radiation-therapy planning.
Clinical fit
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.
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.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K243523 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
DICOM CT workflow with model-specific advanced image objects and planning interfaces; validate downstream compatibility and quantitative consistency.
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. The scanner is not the principal guidance method for invasive procedures. Model, field of view, temporal resolution, spectral function, reconstruction, and radiotherapy support must be matched to the exact system and software.
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.
product family · checked 2026-09-04Vendor productivity claims are scenario inputs, not guaranteed local savings.
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: The scanner is not the principal guidance method for invasive procedures. Model, field of view, temporal resolution, spectral function, reconstruction, and radiotherapy support must be matched to the exact system and software.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
The exact installed deployment, hosting, service, security, and operational boundary remains unverified and requires site-specific confirmation.
exact submission · checked 2026-09-04FDA-described deployment details do not establish current hosting contracts, security controls, uptime, or local qualification.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
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.
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.
Manufacturer bench, phantom, image-quality, dose, reconstruction, safety, software, and workflow validation · Representative head and body diagnostic, screening, interventional, treatment, and radiotherapy-planning CT protocols
exact submission · Tested version: NAEOTOM Alpha family with syngo CT VB20 · Sponsor or vendor studyK243523
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Peer-reviewed clinical technology review and experience report · Patients imaged with clinical photon-counting CT systems
product family · Tested version: Photon-counting CT technology and NAEOTOM product family · Independent studyPMID 37602816
Technology- and product-family evidence; not exact K243523 model-performance proof.
FDA 510(k) verification and validation evidence described in the exact submission · Multi-region
exact submission · Tested version: NAEOTOM Alpha.Peak/Alpha/Alpha.Pro/Alpha.Prime with syngo CT VB20 · Sponsor or vendor studyK243523
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
No separate named-product payment identified in reviewed CMS material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage 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.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 20 PubMed titles and eight trial records. NCT07016477 names the NAEOTOM Alpha family but not the K243523 syngo CT VB20 configuration; all 28 candidates lack exact tested-version linkage and are quarantined. 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 material, peer reviewed literature, clinical trial registry, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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