syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc.syngo.CT Extended Functionality is a software package that provides advanced visualization and measurement tools for medical images acquired from CT and potentially other modalities like MRI. It helps technicians and physicians perform qualitative and quantitative analysis of clinical imaging data to assist in diagnosis by creating detailed images and measurements using various specialized extensions.
Intended Use
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purposes, supporting technicians and physicians in qualitative and quantitative measurements and analysis of clinical data acquired and reconstructed by CT scanners and potentially other medical imaging modalities (e.g., MR scanners).
Technology
syngo.CT Extended Functionality is a software bundle featuring multiple extensions for advanced visualization and measurement on clinical data from CT or other modalities. Key features include the 'Average' extension for pixel-based image averaging, 'Vessel' extension using deep learning for bone removal in vascular evaluations, interactive spectral imaging for dual energy data visualization, oncology tools for nodule localization and evaluation, and AI-based segmentation for pulmonary density assessment. These build on its predicate device with modifications to improve functionality and quality.
Performance
Performance testing included non-clinical integration and functional tests demonstrating that the device performs as intended and meets acceptance criteria. Risk analysis and software verification and validation confirmed safety and effectiveness. The device complies with relevant voluntary standards for medical device software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2022
29 days - 2
FDA Approval
7/13/2022
Other devices from Siemens Medical Solutions USA, Inc.
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