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 scannerin a Digital Imaging and Communications in Medicine (DICOM) Standard format.This software provides tools that can be used for the qualitative and quantitative assessment ofphysician-identified coronary plaques and stenosis in coronary computed tomographyangiography (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 asa replacement to a medical professional’s comprehensive diagnostic decision-making process. Thesoftware’s semi-automated features are intended for an adult population and should only be usedby 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243038000Salix CentralArtrya Limited2025-03-27QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09369900000857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09369900000857093699000008579369900000857

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+61864787816gabriela.quijada@artrya.com

Regulatory Flags#

DUNS number
138348174
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369998252183SalixSalix Coronary Plaque V1.X2026-02-17

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