syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.The syngo.CT CaScoring software by Siemens is used to analyze non-contrast cardiac CT scans to detect and evaluate calcified lesions in coronary arteries. It calculates scores like the Agatston score, mass, and volume scores for different coronary arteries, helping physicians assess coronary artery disease and generate detailed reports to support patient management.
Intended Use
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets, designed to support physicians in evaluating and documenting calcified coronary lesions using spiral or sequential CT scans. It marks lesions and allocates them to coronary arteries, calculating relevant calcium scores and generating reports.
Technology
The software loads non-contrasted cardiac CT images, allows interactive lesion marking and allocation to specific coronary arteries (RCA, LM, LAD, CX), calculates Agatston equivalent, mass, and volume scores for each artery and total scores, and produces a paper report with calcium scoring data and relevant information. The current version includes an enhanced calcium scoring algorithm retrained on a larger database, and user interface modifications.
Performance
Non-clinical integration and functional testing demonstrate software performs as intended. Bench testing of the retrained automatic scoring algorithm showed adequate and acceptable performance for Agatston scores and classification into score categories, meeting all pre-specified acceptance criteria. Risk analysis and validation support substantial equivalence to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/27/2022
20 days - 2
FDA Approval
5/17/2022
Other devices from Siemens Medical Solutions USA, Inc.
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