NAEOTOM Alpha
Siemens Medical Solutions USA, Inc.The NAEOTOM Alpha is a dual-source computed tomography (CT) scanner developed by Siemens Medical Solutions. It uses advanced photon-counting detector technology and incorporates AI-driven image reconstruction and post-processing software to produce highly detailed cross-sectional images. This device assists trained clinicians in diagnosing and treating patients, including applications like low-dose lung cancer screening in high-risk populations. It features enhanced workflow tools, integrated needle guidance for interventions, and supports sophisticated quantitative imaging techniques.
Intended Use
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment and for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations.
Technology
The device is a dual source CT scanner featuring two continuously rotating tube-detector systems with photon-counting detectors (QuantaMax) based on 'Quantum Technology.' It utilizes iterative reconstruction, advanced post-processing software, and supports functions like Scan&GO, myNeedle Guide, and FAST 3D Camera-based patient positioning. The software platform is SOMARIS/10 syngo CT VB10, an evolution of the site-cleared syngo CT VA50 version. Key hardware modifications include improved tin filtration, a modified camera design, and multi-purpose patient table enhancements.
Performance
Extensive non-clinical testing including integration, functionality, and phantom tests confirmed the NAEOTOM Alpha's safety and effectiveness. Bench tests validated new hardware and software features such as FAST 3D Camera workflows, multi-purpose patient table function, artefact correction algorithms (ZeeFree), myNeedle Guide needle detection with 90.76% accuracy, spectral imaging capabilities, and high definition field of view (HD FoV). Cybersecurity protections and wireless coexistence testing for Scan&GO functionality were completed. All software components met acceptance criteria with no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2023
4 months - 2
FDA Approval
3/28/2024
Other devices from Siemens Medical Solutions USA, Inc.
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