SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.The SOMATOM go. Platform and SOMATOM X. Platform CT scanners, produced by Siemens Medical Solutions USA, Inc., are advanced computed tomography systems designed to generate detailed cross-sectional images of patients. These devices aid healthcare professionals in diagnosis, treatment planning, and radiation therapy across a variety of clinical scenarios, including lung cancer screening. The systems feature a fan-beam CT technology, sophisticated software for image reconstruction and optional AI-assisted workflow enhancements such as automated needle detection for intervention procedures, and innovative camera-based patient positioning workflows. They improve clinical accuracy and efficiency while ensuring patient comfort and safety.
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 SOMATOM go. Platform and SOMATOM X. Platform are single source whole body CT scanners using a continuously rotating tube-detector system with fan beam principle. They include advanced hardware features such as Stellar detector technology, various X-ray tubes (Chronon, Athlon, Vectron), tin filtration technology, and option for FAST 3D Camera patient positioning. The software platform (SOMARIS/10 syngo CT VB10) supports patient management, data acquisition, image reconstruction using iterative algorithms, and optional AI-enabled post-processing applications such as myNeedle Guide for needle detection and others.
Performance
Non-clinical testing including integration, functional tests, phantom tests, and bench tests were conducted to verify and validate the device. Specific bench tests demonstrated comparable performance of new hardware components such as the FAST 3D Camera and the AI-based needle detection algorithm (myNeedle Guide) relative to predicate devices. Risk analysis and cybersecurity assessments were completed, along with wireless coexistence and electromagnetic compatibility tests. The device meets recognized consensus standards and FDA guidance requirements, supporting a finding of substantial equivalence and safe effective use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2023
4 months - 2
FDA Approval
3/26/2024
Other devices from Siemens Medical Solutions USA, Inc.
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