Salix

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…

Registry build 21.09.26

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.

8manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QIH
Manufacturer City Province Registered as Device types
Philips Ultrasound (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 5
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4
Wuhan United Imaging Healthcare Co., Ltd. Wuhan Hubei Manufacturer 4
Keya Medical Technology Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for Salix
Listed by Artrya USA Inc.
FDA product code QIH
Device type Automated Radiological Image Processing Software
Device class Class 2
Regulation 21 CFR 892.2050
510(k) K243038
Record published 2026-02-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Salix
Catalogue number Size Status
Salix Coronary Plaque V1.X In distribution
Salix Central V1.X In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imbio RV/LV Imbio, LLC 5
VEA Align EOS imaging 4
Qlab Advanced Quantification Software Philips Ultrasound LLC 3
uOmnispace Shanghai United Imaging Healthcare Co., Ltd. 3
Scenium Siemens Medical Solutions USA, Inc. 3
syngo.MI General Siemens Medical Solutions USA, Inc. 3
Neosoma Dashboard Neosoma, Inc. 3
BriefCase-Quantification Aidoc Medical Ltd. 3
OrthoNext™ Platform System Software Orthofix SRL 3
MI View&GO Siemens Medical Solutions USA, Inc. 3
FEops Feops NV 3
AI-Rad Companion Brain MR Siemens Healthcare Limited 3

Showing 12 of 147. All products under Automated Radiological Image Processing Software

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer