NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.The NAEOTOM Alpha series by Siemens is a computed tomography (CT) scanner system that produces detailed cross-sectional images using X-rays. These images aid clinicians in diagnosis, treatment, radiation therapy planning, and interventions, including low-dose lung cancer screening for high-risk populations. The system uses advanced software for image reconstruction and supports various post-processing applications to deliver clear and precise imaging for multiple clinical uses.
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 a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as 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 single or dual source CT scanner system utilizing photon-counting QuantaMax detectors and advanced image reconstruction software (SOMARIS/10 syngo CT VB20) enabling low-dose imaging and enhanced radiotherapy planning support. It features real-time respiratory motion management, CT View&GO post-processing, laser guidance for interventions, and ergonomic design for professional healthcare facilities.
Performance
Extensive non-clinical testing including integration, functional, and phantom tests were performed, verifying the safety and efficacy of new software features such as Direct i4D respiratory scanning, DirectBreathhold, Recon&GO RT planning for radiotherapy, FAST 3D Camera workflow, and low-dose lung cancer screening. Testing confirmed equivalence to predicate devices with no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2024
3 months - 2
FDA Approval
2/12/2025
Other devices from Siemens Medical Solutions USA, Inc.
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