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 2026-09-03Later 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 2026-09-03Test 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 2026-09-03Define 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 2026-09-03Vendor 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 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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.
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.
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.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 8 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, vendor product page, peer reviewed publication, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
Alternatives
Siemens Medical Solutions USA, Inc.
SOMATOM X.cite and X.ceed with syngo CT VB20 support diagnostic CT, interventions, treatment preparation, radiation-therapy planning, and qualified low-dose lung screening.
Philips Healthcare (Suzhou) Co., Ltd.
CT 5300 acquires head and whole-body cross-sectional CT images for diagnosis in adult and pediatric patients and supports low-dose lung-cancer screening under approved protocols.
Siemens Medical Solutions USA, Inc.
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...
Philips Healthcare (Suzhou) Co., Ltd.
Precise Position uses a ceiling-mounted color and depth camera with a convolutional neural network to assist positioning patients aged 16 years and older on Philips Incisive CT by...