Salix
Basic Information
- Brand Name
- Salix
- Primary DI
- 09369998252183
- Version / Model
- Salix Coronary Plaque V1.X
- Company Name
- ARTRYA USA INC.
- Labeler DUNS
- 138348174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-17
- Public Version
- 1
- Public Version Date
- 2026-02-25
- Public Version Status
- New
- Public Device Record Key
- e87961db-97de-4593-a919-9cdb9d830014
Device Description
Salix Coronary Plaque is a web-based, non-invasive software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format. This software provides cardiologists and radiologists with interactive tools that can be used for viewing and analyzing cardiac computed tomography (CT) data for quantification and characterization of coronary plaques (i.e. atherosclerosis), stenosis and to perform calcium scoring in non-contrast cardiac CT. Salix Coronary Plaque is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional’s comprehensive diagnostic decision-making process. The software’s semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining and evaluating cardiac CT images. Users should be aware that certain views make use of interpolated data. These data are created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63386 | X-ray image interpretive software | An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09369998252183 | GS1 |
Customer Contacts
- Phone
- +61864787816
- [email protected]