Rosa Comp Mini Reamer – Step 1
Catalogue number SSI007723, listed by Zimmer, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Battery Charger EU, Biim Ultrasound
Catalogue number P001198, listed by Biim Ultrasound AS, Norway, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Blackford Platform
Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
MirrorMe3D Nose Model – Baseline
The MirrorMe3D Nose Model Baseline is a patient-specific physical anatomic model for visualizing facial soft tissue during treatment planning. It represents preoperative anatomy and…
Stage
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM…
Syngo Ultrasound Workplace
Catalogue number 10853679, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Sicat Function
SICAT Function visualizes and segments oral and maxillofacial imaging to help dental professionals evaluate treatment options. It uses CT or cone beam CT data as the underlying anatomical…
Vuze System 2.0
The VUZE System (the “System”) enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of…
Edda Technology
IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners
Torana™
The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by…
ZIRKONZAHN.Implant-Planner
Zirkonzahn Implant-Planner is dental software for implant planning and surgical guide design. It imports CT or cone-beam CT DICOM images and turns them into three-dimensional volumes and…
MI View&GO
3 catalogue numbers from 11589575, 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.
Simpleware ScanIP Medical
Final software release for UDI-DI: T-2022.03. Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging…
Syngo Application Software Media
syngo Application Software VD1;syngo Application Software Media;Registered Medical Devices:syngo Application Software – GTIN 04056869012902
Scenium Suite MI Mobile Bundle
Catalogue number 10183755, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Cerner SkyVue®
2 catalogue numbers from SkyVue2014, listed by Cerner Corporation, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
ImagePilot
6 catalogue numbers from V1.93R00E, listed by Konica Minolta, Inc., Japan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
StrokeViewer LVO Triaging
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to…
Ndohd High Definition Imaging System (Ndohd)
The NDOHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic surgical procedures including, but not limited to, orthoscopic,…
ThinkingNet
ThinkingNet: 1 catalogue number listed by Thinking Systems Corp., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Roll Stand + Arm
Catalogue number HRDGN00023, listed by UC-Care, Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
nordicDSC
nordicDSC is medical image post-processing software for analyzing dynamic susceptibility contrast-enhanced MR data from the human brain. The filing says it generates parametric maps that…
Vitrea View
Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and Multi-Media medical images. The Vitrea View…
Aview LCS
2 catalogue numbers from 1.1, listed by Coreline Soft Co., Ltd., South Korea, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Hermia
Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map)…
TeraRecon Cardiac.Chambers.MR
TeraRecon Cardiac.Chambers.MR automatically outlines cardiac chamber structures on contrast or noncontrast MR scans from adult patients. It segments the inner and outer walls of the left…
VMA Image Acquisition Software
VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
IB Delta Suite
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.
MX50N
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
Vue Motion
Vue Motion is a browser-based viewer for portable and remote access to medical images and related patient data. It supports remote reading or referral and distribution of radiology…
MX30N
The FDA filing identifies MX30TQS within the MX30N LCD Monitor System, a display for digital medical images. It is intended for review and analysis by trained medical practitioners. The…
Unifi Workspace
Unifi Workspace is software for viewing and processing mammography, breast tomosynthesis and other DICOM medical images. It supports reference review and diagnostic interpretation by…
OrthoNext™ Platform System Software
Postoperative Tlhexmodule Version 1.1 FOR Orthonext Software
e-CTP
Brainomix 360 e-CTP processes CT perfusion examinations to help clinicians assess changes in contrast over time within brain tissue. It provides viewing, analysis, quantification and…
Tomtec Arena
2 catalogue numbers from TTA2.53, listed by Philips Ultrasound LLC, United States, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
syngo.CT Brain Hemorrhage
2 catalogue numbers from 11546320, listed by Siemens Healthcare Limited, Canada, under Radiological Computer-Assisted Triage And Notification Software. 1 manufacturer in China is registered for this product code.
BrainSpec Core™ Software
BrainSpec Core is postprocessing software for analyzing magnetic resonance spectroscopy data. It supports single voxel spectroscopy and chemical shift imaging, providing metabolic…
syngo.MI Reading
4 catalogue numbers from 10764088, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
SurgicalAR
Catalogue number 1.1.0.0, listed by Medivis, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
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…
VolparaDensity
VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)
CDM Insights
CDM Insights is software that analyzes brain MRI images for trained healthcare practitioners. It automatically segments brain structures and white-matter hyperintensities and calculates…
Rosa® Shoulder
20 catalogue numbers from 20-8087-400-00, listed by Orthosoft, Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Opulus Lymphoma Precision
Opulus Lymphoma Precision is software that segments and visualizes lesions in whole-body FDG-PET/CT scans of patients already diagnosed with FDG-avid lymphoma. It calculates total metabolic…
CW120N
CW120N is an LCD medical monitor for presenting high-resolution color and grayscale medical images in PACS and radiology systems. The filing identifies trained medical practitioners as…
BriefCase-Quantification
BriefCase-Quantification measures the maximum axial diameter of the abdominal aorta on contrast-enhanced CT examinations. It is intended to assist trained specialists reviewing adult…
Modus Plan
3 catalogue numbers from 2.1, listed by Synaptive Medical Inc, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Rosa Comp Mini Reamer Assy Block
Catalogue number SSI007728, listed by Zimmer, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Synapse Mobility
The device is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D…
Syngo Application Software
syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Codonics Horizon® GS Multi-Media Imager
Codonics Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 3 Media Input
Heuron ICH
Heuron ICH is software that flags suspected intracranial hemorrhage on noncontrast head CT scans to help prioritize review. It is intended for patients aged 18 and older and runs alongside…
RConsole1
The Rconsole1 is intended for use with mammographic images acquired using digital breast x-ray systems.
Merge PACS
Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and…
Mimics Cardiac Planner
Mimics Cardiac Planner is online software for reviewing and adjusting plans for structural heart and vascular procedures. It presents DICOM images, three dimensional models, landmarks and…
Quentry Subscription
Catalogue number 3.1, listed by Brainlab SE, Germany, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Workflow Box
4 catalogue numbers from 2.2, listed by Mirada Medical Limited, United Kingdom, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
aiOS
The AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing by Integrated AI Solutions (IAIS), and to display their…
Sicat Endo
SICAT Endo is software for viewing and analyzing oral and maxillofacial imaging to support endodontic diagnosis and treatment planning. It brings together three dimensional CT or cone beam…
Qlab Quantification Software
3 catalogue numbers from Release 10.7, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Curve Image™
Curve Image™ is a cloud-based dental image acquisition and management system that provides Internet access to an image library for each patient in a practice. It also provides tools for…
Icobrain Mr
icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate…
Rosa Cup Inserter Screw
Catalogue number 20-8060-305-00, listed by Orthosoft, Inc., Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Epiq 5 Diamond Select Ultrasound System
Catalogue number 795120, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Merge Unity PACS
5 catalogue numbers from 11.2, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Image Fusion
Catalogue number 5.0, listed by Brainlab SE, Germany, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
ClariPlatform
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment. The system facilitates the…
XVWeb
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.
Archimedes Planning System
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of…
ContourProtégéAI
3 catalogue numbers from 1.2, listed by MIM Software Inc., United States, under Radiological Image Processing Software For Radiation Therapy. 2 manufacturers in China are registered for this product code.
Techfit
Digitally Integrated Surgical Reconstruction Platform - DISRP
Syngo Imaging
syngo Imaging VB36E"Stock Keeping Unit B" - product label DVD Media Covercontaining the following upgrade Stock Keeping Unit's.This unit contains the following registered Medical Device:(1)…
WebCeph
WebCeph is a two-dimensional orthodontic analysis program that manages patient information and images. The filing describes image analysis, profilograms, superimpositions and visual…
Origin Data Management / Patient Data Manager
2 catalogue numbers from 2.3.1, listed by Brainlab SE, Germany, under Digitizer, Image, Radiological. 1 manufacturer in China is registered for this product code.
Olea S.I.A. Neurovascular
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals…
Probe Sensor Assembly for Hitachi V53W
Catalogue number FPRSA00012, listed by UC-Care, Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
DRX – Ascend System
QG-TV10-C Techvision RS-590 With Q-Visio
CS-7
4 catalogue numbers from A4C1, listed by Konica Minolta, Inc., Japan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Elements Viewer
Catalogue number 5.2, listed by Brainlab SE, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Patient Specific Planning Solution™
Catalogue number 110046598, listed by Biomet Orthopedics, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
D&K Stepper Template Fixator
Catalogue number FPRSA00021, listed by UC-Care, Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
W1500E
15.6” Multi-Touch Chassis Display Projective-Capacitive Touch Monitor with European Power Cord
VSP System, VSP Cranial
A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of time. Once the bone repositioning guide stabilizes the position of the patient’s bone; the…
Change Healthcare Cardiology
9 catalogue numbers from 15.1.4, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Caas Workstation
12 catalogue numbers from 7.4, listed by PIE Medical Imaging B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
AccuContour
It is used by oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and…
mediCAD®
mediCAD®: 1 catalogue number listed by mediCAD Hectec GMBH, Germany, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Probe Sensor Assembly for Hitachi EUP-U533
Catalogue number FPRSA00018, listed by UC-Care, Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Neosoma Dashboard
Neosoma Dashboard: 3 catalogue numbers listed by Neosoma, Inc., United States, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.