Horos MD
HorosMD is macOS software for viewing medical images in two and three dimensions. It allows trained healthcare professionals to review diagnostic imaging, including CT and MRI studies, and…
Caas IntraVascular
3 catalogue numbers from 2.1, listed by PIE Medical Imaging B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Epiq CVxi Ultrasound System
Catalogue number 795232, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Showcase®
ShowCase Image Center is an image management application that can automatically receive images from most DICOM capable imaging devices.
MREplus
2 catalogue numbers from MREplus 3.0.0WIN, listed by Resoundant, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
TruPlan
TruPlan is medical imaging software for planning a left atrial appendage closure procedure. It uses pre-existing CT images to support assessment of the left atrial appendage and nearby…
InferRead CT Stroke.AI
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital…
VEA Align
VEA Align assists global skeletal alignment assessment using frontal and lateral X-rays from EOS or EOSedge systems. A machine-learning algorithm proposes anatomical landmarks, which the…
AiMIFY
AiMIFY is an image processing software that can be used for image enhancement in MRI images. It can be used to increase contrast-to-noise ratio (CNR), contrast enhancement (CEP), and…
Imbio RV/LV
Imbio RV/LV processes CT pulmonary angiography images to measure the maximum right- and left-ventricular diameters and calculate their ratio. Its algorithms segment the ventricles and place…
Msoft Dental Planning System
4 catalogue numbers from 2.22, listed by Swissmeda AG, Switzerland, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
ClearCanvas Personal Edition Workstation
Catalogue number 13.1, listed by Synaptive Medical Inc, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Impax Clinical Applications
IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
dicomPACS®DX-R
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an…
Vue PACS (Diagnostic)
The Vue PACS diagnostic client is web deployable and has a variety of user profiles applicable to different stakeholder in the cycle of care such as radiologists, referring physicians,…
Q-Station
3 catalogue numbers from Release 3.8.5, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Konicaminolta DI-X1
Konicaminolta DI-X1: 5 catalogue numbers listed by Konica Minolta, Inc., Japan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Medws
13 catalogue numbers from 5.4, listed by Med.e.com, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Curie|ENDEX
Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM…
Vitrea Software Package
Catalogue number VSTP-002A, listed by Canon Inc., Japan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
BrainInsight
Catalogue number Version 1.0, listed by Hyperfine Operations, Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
40003 PercuNav Coaxial Needle Tracker, 16g X 11 Cm
Catalogue number 989605428004, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Hdmd PRO
HDMD Pro Update the current LiFePO4 Battery 18650 1500mAh-3.2V to LiFePO4 Battery 18650 1800mAh-3.2V
HealthMyne
14 catalogue numbers from 11.1, listed by Healthmyne, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Diva
2 catalogue numbers from ZSP2105CMI, listed by Diva Laboratories, Ltd., Taiwan, under Display, Diagnostic Radiology. 5 manufacturers in China are registered for this product code.
Neosoma HGG
Neosoma HGG: 2 catalogue numbers listed by Neosoma, Inc., United States, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
syngo.SPECT Processing
4 catalogue numbers from 10909200, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Holoscope
HOLOSCOPE-i is a medical display workstation for 3D image visualization and interaction. It generates holograms from volumetric data acquired from CT and ultrasound sources. The system…
Nio 3MP LED
The Barco Nio 3MP LED MDNG-3220 is a grayscale flat panel display for reviewing and analyzing medical images. It is intended for trained medical practitioners and excludes digital…
ImagenQ
The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative…
TechLive
The FDA filing identifies TechLive as software for remote access to medical imaging devices across locations. It supports real-time image acquisition, assistance, review, monitoring and…
Caas MR Solutions
3 catalogue numbers from 5.3, listed by PIE Medical Imaging B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Synapse CardioVascular
Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.
Preview
The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic…
Biim iOS App, P1.3.1
Catalogue number P001402, listed by Biim Ultrasound AS, Norway, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Quantib Prostate
Quantib Prostate is MRI post-processing software that helps clinicians view, segment and analyze prostate images. It registers multiparametric scans and provides tools for prostate-volume…
Visage Ease Pro
5 catalogue numbers from 1.8.2, listed by Visage Imaging GmbH, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Syngo Carbon Space
Syngo Carbon Space is software for reviewing and analyzing medical images and distributing images and results within healthcare institutions. It runs on compatible computing hardware, with…
Apex Cloud Software
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
Corridor4DM
This applies to minor versions referred to as v2018, v2023, v2024, v2025
Icobrain
icobrain is software intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images.
Syngo.plaza
syngo.plaza is picture archiving and communication software for displaying, processing, reading, reporting, sharing and storing medical images. It supports diagnosis and treatment planning…
Avatar Medical Vision
Avatar Medical Vision is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired…
Synapse Radiology PACS
Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts…
D-Scope Server Software
D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR…
ClearRead Compare Console
2 catalogue numbers from 4.0.0, listed by Riverain Technologies, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
IB FTB Express
Catalogue number 2.0, listed by Imaging Biometrics, LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Brainlab Elements Image Fusion
Catalogue number 4.5, listed by Brainlab SE, Germany, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
Limbus Contour
Limbus Contour is software that automatically segments normal tissues on CT or MR images for radiation treatment planning. It uses pretrained machine-learning models and additional…
AccuPlan System
Orthognathic, Surgical Planning KIT W/ 3D Printed Titanium Plates AND Guides, Single JAW Bundle
EchoGo
Catalogue number Workstream 1.0, listed by Ultromics, Ltd., United Kingdom, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Hisense
The FDA summary identifies the Hisense LCD monitor models HMD2C21A, HMD4C27S and HMD6C30D. These monitors are intended for trained medical practitioners to view medical images and provide…
Box for ExamVue PACS(Outside 265mmx185mmx150mm)
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server…
Codonics Virtua® C Controller – 90c
Virtua C DICOM Server/Publisher Controller -90C
Andi
ANDI 2.0 displays medical images and healthcare data and processes MR images for visualization, segmentation and volumetric measurement of brain structures. The output is generated for use…
Blue Sky Bio, LLC.
2 catalogue numbers from 4.12, listed by Blue SKY BIO, LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Coronis 5MP Mammo
3 catalogue numbers from MDMG-5121, listed by Barco, Inc, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Syngo MBF
syngo MBF is software for visualizing, assessing and quantifying myocardial blood flow from PET images. It launches through the OpenApps framework within the syngo.via molecular imaging…
Aspire Bellus II
ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading,…
Drypro Model 832
2 catalogue numbers from GM76, listed by Konica Minolta, Inc., Japan, under Camera, Multi Format, Radiological. 2 manufacturers in China are registered for this product code.
Cercare Medical Neurosuite (CMN) Capillary Function With Virtual Expert
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 18
Vessel Analysis for ORS Visual
Vessel Analysis is a post-processing add-on module for ORS Visual that enables radiologists, cardiologists, vascular surgeons, and interventionalists to quickly and confidently evaluate CT…
Brainlab Elements Image Fusion Angio
Catalogue number 1.0, listed by Brainlab SE, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
CADstream
5 catalogue numbers from 6.5, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Move Forward Software
Catalogue number CG100, listed by Biomet Orthopedics, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
EchoNavigator
Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo…
660HD-E Image Management System
SVC Repl 660HD-E Image Management System
Clinical Review 1MP
3 catalogue numbers from MDRC-1119, listed by Barco, Inc, United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
PowerLook 10 PRO+, Tower OUS
Catalogue number DSC011-02-OUS, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
ClearRead Enhanced Docker
ClearRead Enhanced on Docker Platform. Primary DI Number mistype as M722XD20104E20370. Original submission date 5/19/2020.
Sicat Suite
3 catalogue numbers from V2.0, listed by Sicat Gmbh & Co. KG, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
syngo.MI General
3 catalogue numbers from 11431560, listed by Siemens Medical Solutions USA, Inc., United States, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
Starpacs Dental
Catalogue number STARPACS Dental, listed by Infinitt Healthcare Co., Ltd., South Korea, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
MammoScape
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital…
DentalEye
2 catalogue numbers from Viewer, listed by Dentaleye AB, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
ZedView
Catalogue number Ver.14.0.4.1, listed by Lexi Co., Ltd., Japan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Prima
Catalogue number PRIMA, listed by Hologic, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
UpLinq
Client site located software application that receives IAD-generated data and provides the mechanism by which patient information is transferred to the Application Server (UltraLinq) via…
PowerLook 11.2
Catalogue number Version 11.2, listed by Icad Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Buzz Virtual
Catalogue number 15501, listed by Brainlab SE, Germany, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
RadimetricsTM Enterprise Platform
"RADIMETRICS Enterprise Platform (60777193)"
Neurophet Aqua
2 catalogue numbers from 3.1, listed by Neurophet, Inc., South Korea, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
ClearRead CT Docker
ClearRead CT on Docker Platform. Original Commercial Distribution Date: 2020-05-19. Mistyped as M722CD20105V20040.
Mimics
The FDA filing identifies Mimics Medical as image processing software. It can import, display, and segment medical images, then create digital 3D models for measuring, treatment planning,…
IB DCE
2 catalogue numbers from 2.0, listed by Imaging Biometrics, LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Lilly Together
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
Quantib ND
7 catalogue numbers from 2.0, listed by Quantib B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.