Micsi-RMT
MICSI-RMT is image processing software that reduces noise in MRI images of the head. It handles functional and diffusion MRI data and is intended for radiologists working in imaging…
Vitrea View
Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software…
ClearRead Confirm Console
2 catalogue numbers from 3.0.0, listed by Riverain Technologies, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Focalyx Fusion
The Focalyx Fusion system is designed for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. The…
Materialise Mimics Enlight CMF
Materialise Mimics Enlight CMF is image processing software for diagnosis and treatment planning in maxillofacial procedures. It imports and displays medical images, segments regions of…
iQ-SYSTEM PACS
iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
Efilm Workstation
3 catalogue numbers from 4.3, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
SwiftMR
SwiftMR is stand-alone software for accepting, enhancing and transferring MRI images in DICOM format. It is intended for images from all body parts and can reduce noise and increase image…
Infinitt PACS, Infinitt G3, Infinitt Mammo
Catalogue number INFINITT PACS, listed by Infinitt Healthcare Co., Ltd., South Korea, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Digital Expert Access
DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
Joints
The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on…
PowerLook 10 PRO+
Catalogue number V10, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
NilRead
The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic…
Ashvins Variant Ashvins Diagnostic Workstation
Ashvins Diagnostic Workstation is medical image software used by trained professionals to view, process and report digital images. It supports clinical interpretation and treatment planning…
syngo.MR General
Catalogue number 11291457, listed by Siemens Healthcare Limited, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Sectra Workstation
Sectra Workstation is a software-only device intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information.…
Sectra Orthopedic Package
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has…
Image Diagnostics, Inc
Idi,mobile Video Display System,single 55IN. Monitor,telescopic,ilex W/IPS500A,120V,#A280-0600 OR W/IPS1000A #A280-0700
Syngo.via View&GO
syngo.via View&GO is software for viewing, manipulating, communicating and storing medical images. The VA10A version provides a standalone reading workplace for radiology, nuclear medicine…
Exini Bone
EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medical image viewers, view…
Carpl
CARPL, a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images…
ClearRead CT Server
16 catalogue numbers from 5.11.1, listed by Riverain Technologies, United States, under Lung Computed Tomography System, Computer-Aided Detection. 1 manufacturer in China is registered for this product code.
Anatomage Table
Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating…
IBM Iconnect Access
5 catalogue numbers from 7.2, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Velocity
3 catalogue numbers from 4.3, listed by Varian Medical Systems, Inc, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Probe Sensor Assembly for GE E8CS
Catalogue number FPRSA00014, listed by UC-Care, Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Battery Charger, Biim Ultrasound
Catalogue number P001052, listed by Biim Ultrasound AS, Norway, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
CoverScan
CoverScanMD is a standalone, post-processing software as a medical device (SaMD) specifically designed for the processing and analysis of magnetic resonance imaging (MRI) data. It enables…
MedDream
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is…
Scenium
The FDA filing names Scenium as a neurology software application within syngo.via MI Workflows and describes the software as a multi-modality postprocessing device. The filing states that…
Cenova
Cenova™ image analytics server is a high-performance application server that provides proprietary software applications to assist radiologists in the analysis of digital mammography images.
Eureka
Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and…
Pelvic Case
Catalogue number MAS2965-01, listed by Mazor Robotics Ltd., Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
syngo.MR Spectroscopy
3 catalogue numbers from 11234874, listed by Siemens Healthcare Limited, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Adas 3d
6 catalogue numbers from V2.8, listed by ADAS3D Medical S.L, Spain, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Breast Arterial Calcification (BAC)
BAC is software that helps qualified physicians identify breast arterial calcifications during review of screening mammograms. It analyzes compatible full field digital mammography and…
Caas MRV
3 catalogue numbers from 4.3, listed by PIE Medical Imaging B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
PowerLook 10 PRO+, Rack Mount, OUS
Catalogue number DSC011-04-OUS, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Viz SDH (Viz Subdural)
Viz SDH v1.16 (2026-07-01)
Arterys Cardio DL
2 catalogue numbers from CVM2, listed by Arterys Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
vascuCAP
2 catalogue numbers from A.1.2, listed by Elucid Bioimaging, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
BriefCase
BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
System, Digital Image Communications, Radiological
DVI Four Fiber Output Module
4klearity
4Klearity Med X Change Brand Software Version 7.12.1.2
LG
11 catalogue numbers from 21HQ613D, listed by LG Electronics Inc., South Korea, under Display, Diagnostic Radiology. 5 manufacturers in China are registered for this product code.
VISIUSmatrix
Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
Codonics Horizon® Multi-Media Imager
Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager - 51C
E-Ortho Shoulder Software
Catalogue number 0100011575, listed by Fournitures Hospitalieres Industrie, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Showcase®
ShowCase Basic and Premier are software applications for viewing medical images.
Rosa Quick Connect Interface
Catalogue number 20-8060-001-00, listed by Orthosoft, Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Synthesis Vision Viewer
13 catalogue numbers from 2.11, listed by Synthesis Health Intelligence Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Autoplaque
Autoplaque software performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms. The software…
Probe Sensor Assembly for D&K 8848
Catalogue number FPRSA00016, listed by UC-Care, Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Mintlesion™
The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological…
Site Rite 8 Ultrasound System
4 catalogue numbers from SR8v3.1.0, listed by Bard Access Systems, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
IBM Iconnect Access 8.1
Catalogue number 8.1, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Cercare Medical Neurosuite With Capillary Function
Cercare Medical Neurosuite with Capillary Function, release 2023-02-01 and prior
XR90 System, Logiq, Upgrade Kit
Catalogue number XR90-LQ-UPGRADE, listed by Mediview XR, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Clio
2 catalogue numbers from Clio #2, listed by Sota Precision Optics, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
McKesson
PAPER, VIDEO UPP 110 HD STANDARD High Density
Syngo Dynamics
syngo.Dynamics VA10BStock Keeping Unit B - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo Dynamics - GTIN 04056869019994
Reformat Gateway
Catalogue number Reformat Gateway, listed by Infinitt Healthcare Co., Ltd., South Korea, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Pre-Sure
End Users of the PRE-SURE device receive digital and/or physical patient anatomical models from Lazarus 3D. The physical models are intended for adjunctive use along with other diagnostic…
TraumaCad
Catalogue number 2.5, listed by Brainlab Ltd., Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
ScaleOR
Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, No Accessory, ND-00B-014/0
PowerLook 11 PRO+, FRU
Catalogue number D4D0248, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Synapse Mobility
Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side rendering technology to stream imaging securely and fast to…
ProFound AI 3.1
2 catalogue numbers from 3.1, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Elements Image Fusion
Elements Image Fusion: 3 catalogue numbers listed by Brainlab SE, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Clever One
Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports…
ImmersiveTouch
ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical…
e-CTA
Brainomix 360 e-CTA processes CT angiography images to visualize large cerebral vessels and compare the brain’s two hemispheres. Image registration and contralateral comparison produce a…
PACS Scan Web
Catalogue number 3.X, listed by Hyland LLC, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
EBM
Catalogue number UniWeb 360, listed by EBM Technologies, Inc., Taiwan, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
DTX Studio™ Clinic
DTX Studio Clinic 3.3 for Win 64-bit limited
Radlink Laser Pro 16
The Radlink Laser Pro 16 is a film digitization system that follows a three-step process of acquiring, selecting, and sending digitized films to any desired destination. A laser beam light…
Intuition
The listed iNtuition Server belongs to the iNtuition software system named in the FDA filing. The filing describes configurations that can provide image review, communications, archiving,…
Syngo MultiModality Workplace
syngo.MMWP VE61B SW UpgradeStock Keeping Unit B - product label DVD Media CoverThis unit contains the following registered Medical Device:(1) syngo MMWP - GTIN 04056869004631syngo.MMWP…
CEPHX3D
CEPHX3D analyzes dental and craniomaxillofacial image information and processes and displays images to support diagnosis and treatment planning. The software is intended for patients aged…
ClearRead CT Platform Docker
7 catalogue numbers from 5.11.1, listed by Riverain Technologies, United States, under Lung Computed Tomography System, Computer-Aided Detection. 1 manufacturer in China is registered for this product code.
Medis Suite Mrct
Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. This includes: - double oblique review of MR…
Medis Suite XA
Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the…
Illumeo
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical…
KIT Danish 660HD-E IMS
Catalogue number 72204714, listed by Smith & Nephew, Inc., United States, under Device, Digital Image Storage, Radiological. 6 manufacturers in China are registered for this product code.
MiPACS Dental Enterpise Viewer
MiPACS Dental Enterpise Viewer: 1 catalogue number listed by Apryse Software Corp., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Saige-Density
Catalogue number 2.1.0, listed by Deephealth, United States, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
ClearRead Xray Compare
ClearRead Xray +Compare on Connect Platform
DaTQUANT
2 catalogue numbers from 2.0, listed by G E Medical Systems Israel Ltd., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
PeekMed Web
PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In the case of a 3D environment, the healthcare professional can…
Enlitic Curie
The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for…
QFR
QFR is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QFR enables interventional cardiologists and researchers to obtain…