syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.
Intended Use
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets designed to support the physician in evaluating and documenting calcified coronary lesions.
Technology
Post-processing application on the syngo.via platform; uses an automated calcium scoring algorithm that assigns a probability of calcification based on location, density, shape, and other properties; generates Agatston equivalent score, mass score, and volume score per coronary artery and overall; supports DICOM data export to generic viewers.
Performance
Software verification and validation conducted according to FDA guidance. Bench testing showed the automated calcium scoring algorithm performed as intended across test data, with adequate accuracy in predicting calcium risk categories. Non-clinical integration and functional tests confirm device safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2019
2 months - 2
FDA Approval
12/17/2019
Other devices from Siemens Medical Solutions USA, Inc.
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