Imbio’s Coronary Artery Calcification (CAC) software is a set of automated image post-processing algorithms designed to help radiologists and cardiologists determine the location and…
Imbio’s Coronary Artery Calcification (CAC) software is a set of automated image post-processing algorithms designed to help radiologists and cardiologists determine the location and calculate the amount of calcification within the coronary arteries in patients who have undergone a non- contrast, chest computed tomography (CT), by providing visualization and quantification of abnormal coronary CT densities. The Imbio CAC software runs automatically on the input CT series, with no user input or intervention. The Imbio CAC software analyses high resolution CT DICOM images of the heart. The Imbio CAC algorithm provides a DICOM or PDF summary report with the results of the analysis.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Imbio CAC | Listed by | Imbio, LLC, United States |
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| 510(k) | K230112 |
| Record published | 2023-07-19 |
| Record revised | 2023-12-04 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.