Syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.
Intended Use
Image analysis software package for evaluating CT data sets, designed to support the physician in evaluating and documenting calcified coronary lesions using non-contrasted cardiac CT images.
Technology
Post-processing software that loads non-contrasted cardiac CT images, applies an automated calcium scoring algorithm to detect and label calcifications in coronary arteries (RCA, LM, LAD, CX), calculates Agatston equivalent, mass, and volume scores, and generates reports. The algorithm was enhanced in this version to label calcifications by vessel and includes UI improvements.
Performance
Non-clinical performance tests and a reader study demonstrated that the algorithm performs adequately and acceptably in automatically scoring coronary calcium and assigning calcifications to specific coronary arteries. The results met all pre-specified acceptance criteria, supporting the claim of substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/20/2020
24 days - 2
FDA Approval
5/14/2020
Other devices from Siemens Medical Solutions USA, Inc.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.