Salix
Basic Information
- Brand Name
- Salix
- Primary DI
- 09369900000857
- Version / Model
- Salix Central 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
- f909736c-8649-471d-9826-54e013ed5b84
Device Description
Salix Central is a web-based 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 tools that can be used for the qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT. Salix Central 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. Salix Central is a prescription use only device.
Device Characteristics
- Single Use
- No
- 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 | 09369900000857 | GS1 |
Customer Contacts
- Phone
- +61864787816
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243038 | 000 |