Salix

Primary DI
09369900000857
Brand
Salix
Company
ARTRYA USA INC.
Model
Salix Central V1.X
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.
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications

CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions

SubmissionSupplement
K243038000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243038000Salix CentralArtrya Limited2025-03-27QIH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09369900000857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09369900000857093699000008579369900000857

GMDN Terms

TermDefinition
X-ray image interpretive softwareAn 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].

Sterilization Methods

Method

Contacts

PhoneEmail
+61864787816gabriela.quijada@artrya.com

Regulatory Flags

DUNS number
138348174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandModelCatalogPublished
09369998252183SalixSalix Coronary Plaque V1.X2026-02-17

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