HealthCCSng cardiac solution
Nanox.AI*Previously part of Zebra Medical Vision
|
Information source:
Public
Last updated: January 21, 2022 |
General Information
| General | |
|---|---|
| Product name | HealthCCSng cardiac solution |
| Company | Nanox.AI |
| Subspeciality | Cardiac |
| Modality | CT |
| Disease targeted | Cardiovascular disease |
| Key-features | Coronary artery calcium detection |
| Suggested use | |
Technical Specifications
| Data characteristics | |
|---|---|
| Population | Adult patients above the age of 30 |
| Input | |
| Input format | |
| Output | Three-category estimation of calcium quantity, preview axial image of the detected calcium |
| Output format | |
| Technology | |
| Integration | |
| Deployment | |
| Trigger for analysis | |
| Processing time | |
Regulatory
| Certification | |
|---|---|
| CE |
Certified,
Class IIa
, MDD
|
| FDA | 510(k) cleared , Class II |
| Intended Use Statements | |
| Intended use (according to CE) | |
Market
| Market presence | |
|---|---|
| On market since | 2021-09-01 00:00:00 |
| Distribution channels | Nuance PIN |
| Countries present (clinical, non-research use) | |
| Paying clinical customers (institutes) | |
| Research/test users (institutes) | |
| Pricing | |
| Pricing model | |
| Based on | |
Evidence
| Evidence | |
|---|---|
| Peer reviewed papers on performance | |
| Non-peer reviewed papers on performance | |
| Other relevant papers | |