OrthoView
OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks,…
Tims System
TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live…
Imagegrid Radiology Viewer System
The ImageGrid® PACS is a software system intended for professional use only, by prescription in United States. Diagnosis is not performed by the software but by Radiologists, Clinicians and…
Fivos PACS
Fivos PACS: 1 catalogue number listed by Fivos, Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Rapid
Rapid Platform plus cleared indications for Rapid version 6.x
MiiS Horus Endoscope Display System -Video Box
A plug-and-play visualization device that works with a disposable endoscope to project images onto a monitor.
Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion
Catalogue number OPALACQ 04-02-01-000, listed by Konica Minolta Medical Imaging U.S.A., Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
RadiForce®
The filing identifies the RadiForce GX570 as a monochrome LCD monitor for viewing medical images, including mammography images. Its stated use is review, analysis and diagnosis of clinical…
syngo.MR Oncology
Catalogue number 11234865, listed by Siemens Healthcare Limited, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
ClearRead CT
ClearRead CT on Docker Platform Primary DI Number should be M722D19154V191210. Re-entered on 12/30/2020.
D-Spect ® Processing and Reviewing Workstation
Single Photon Emission Computed Tomography system, stand alone processing station.
UniSyn
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology…
I-Dixel
25 catalogue numbers from i-Dixel, listed by J. Morita MFG. Corp., Japan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Move Forward Report 10-15
Catalogue number CG003, listed by Biomet Orthopedics, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
IntelliSpace Clinical Applications
Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf"…
inHEART Models Explorer
inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT…
3DIEMME RealGUIDE
RealGUIDE is a software platform for dental and maxillofacial imaging, treatment planning and device modelling. Its desktop application imports CT or cone-beam CT DICOM images for…
Neosoma Brain Mets
Neosoma Brain Mets is software for semiautomatic segmentation of previously diagnosed brain metastases on contrast-enhanced T1 MRI. It uses an artificial-intelligence model to delineate the…
Promap Lite – 3d Prostate Suite
ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during…
Imorgon Medical, LLC
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component.…
Roentgen Works
Roentgen Works 7.2.2 is a PACS, RIS, and Viewer.
syngo.MM Oncology
3 catalogue numbers from 11431557, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
System, Image Processing, Radiological
146 catalogue numbers from PP-0389, listed by Biomet Microfixation, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
qER
Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for signs of intracranial hemorrhage, midline shift, mass effect or…
IntelliSpace Cardiovascular
Philips IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all…
Super Ulstar
9 catalogue numbers from SUPER ULSTAR-2100HD, listed by Durico C&T, Inc., South Korea, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
PointCloud Knee Instruments
34 catalogue numbers from UKI0201-R, listed by Unik Orthopedics, Inc, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
hipEOS
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form…
Caas Qardia
4 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.
XD
3 catalogue numbers from 4.0, listed by Mirada Medical Limited, United Kingdom, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
FlexView Diagnostic
FlexView Diagnostic is a browser-based viewer for medical images and related information. It connects to imaging sources such as PACS or server storage so authorized clinicians can view and…
Chili Pacs
CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning.
Drystar Axys XL
Catalogue number 5367/400, listed by Agfa Healthcare Inc., Canada, under Camera, Multi Format, Radiological. 2 manufacturers in China are registered for this product code.
Jusha
16 catalogue numbers from C620G, listed by Nanjing Jusha Display Technology Co., Ltd., China, under Display, Diagnostic Radiology. 5 manufacturers in China are registered for this product code.
Visible Patient Suite
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment…
Fusionsync
FusionSync is a software program that provides a registration engine to align (register) pairs of images from same and different imaging modalities. The platform-independent registration…
Syngo.via WebViewer
syngo.via WebViewer VA12AStock Keeping Unit B - product label DVD Media CoverThis unit contains the following registered Medical Device:(1) syngo.via Webviewer GTIN 04056869004754
ClearRead Bone Suppression
ClearRead Xray Bone Suppression on Docker Platform
Veolity
1.7.0.228241, Release date: 2021-03-18 1.7.1.252491, Release date: 2022-03-25
WorkstationOne™
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture…
HealthMyne Qids
18 catalogue numbers from 8.3, listed by Healthmyne, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
EBM
12 catalogue numbers from SoliPACS™ Client Viewer, version 4.0, listed by EBM Technologies, Inc., Taiwan, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
NovaMG
NovaPACS™ is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS™ contains…
RamSoft
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage,…
Arterys Viewer
2 catalogue numbers from AVM3, listed by Arterys Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Epiq 7 Diagnostic Ultrasound System
Software version - 10.0.x
MiPACS HTML5 Web Viewer
MiPACS HTML5 Web 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.
AmCAD UT Detection
AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound…
Evolution4K
Evolution4K Recording System - HDMI 2.0/3G-SDI Version Software Upgrade from version 1.6.2 to 1.7.26
Vitrea Read
Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various…
syngo.MI Cardiology
5 catalogue numbers from 11431558, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
VSP System
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may…
Syngo.via
syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover "HF02": Unit contains following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional…
Battery, Biim Ultrasound
Catalogue number P001050, listed by Biim Ultrasound AS, Norway, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
EzDent-i
EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM…
Blackford Registration Application
Blackford Registration Application v1.2.x, supplied with Blackford Platform (part of the Blackford Product Family)
3mensio Workstation
15 catalogue numbers from 10.2, listed by PIE Medical Imaging B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Cercare Medical Neurosuite
Cercare Medical Neurosuite release 2023-02-01 and prior
AI Metrics
The FDA filing identifies AI Metrics as software for viewing, manipulating, communicating, storing, annotating, analyzing and comparing medical images. It supports CT and MR images and…
RSI-MRI+
RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images…
ClearRead Enhance 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.
Visix
Visix software for use with just an intraoral camera version 2.3.10
UroNav
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined…
I-Rapha View
Catalogue number I-Rapha View, listed by IRM Inc., South Korea, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
ClearRead CT Console
20 catalogue numbers from 5.5.0, listed by Riverain Technologies, United States, under Lung Computed Tomography System, Computer-Aided Detection. 1 manufacturer in China is registered for this product code.
Vitrea Advanced Visualization
Canon Medical’s Vitrea Advanced Visualization is a multi-modality software suite for processing and analyzing clinical images. Its applications work with CT, MR, X-ray angiography, PET,…
Coronis Fusion 6MP LED
3 catalogue numbers from MDCC-6430, listed by Barco, Inc, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Change Healthcare Stratus Imaging Viewer
18 catalogue numbers from 1.0.25, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Vitrea Advanced Visualization
17 catalogue numbers from 7.11.6, listed by Canon Medical Informatics, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Quantib Brain
2 catalogue numbers from 1.5, listed by Quantib B.V., Netherlands, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Efilm Lite
3 catalogue numbers from 4.2, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Orpheus Cast Mobile App Android OS
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality…
V3D-Colon
V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan,…
EndoNaut Workstation
Accessory of medical device EndoNaut (Standalone) SW (UDI: 03760262480022)
Genoray
Triana is a computer-based dental imaging software package identified in the FDA summary by model name. The software obtains medical images from CT and cephalometric or panoramic X-ray…
SonoSync
SonoSync is Samsung Medison’s software solution for live streaming images acquired through ultrasound systems to healthcare professionals. The FDA filing describes remote diagnostic image…
Drystar Axys
Catalogue number 5367/100, listed by Agfa Healthcare Inc., Canada, under Camera, Multi Format, Radiological. 2 manufacturers in China are registered for this product code.
interWORKS
16 catalogue numbers from 8.5.0.20530, listed by Avreo, Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
D-Spect®
3 catalogue numbers from 003, listed by Spectrum Dynamics Medical Ltd., Israel, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Thinq
2 catalogue numbers from 1.1.3, listed by Corticometrics, LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Qlab Advanced Quantification Software
Software Revision 15.5
NEC
5 catalogue numbers from MD212C2, listed by Nec Display Solutions, Ltd., Taiwan, under Display, Diagnostic Radiology. 5 manufacturers in China are registered for this product code.
Ambra PACS
2 catalogue numbers from 3.16.10.0, listed by Ambra Health, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Synapse Enterprise Viewer
Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting,…
System, Image Processing, Radiological
AIDA compact II HD Frame Grabber Board
Triage Stroke
5 catalogue numbers from 14.1, listed by Brainomix Limited, United Kingdom, under Radiological Computer-Assisted Triage And Notification Software. 1 manufacturer in China is registered for this product code.
MIM
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
LungPoint Planning System, V3.2
LungPoint 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…
Change Healthcare Mammography Plus
5 catalogue numbers from 14.0, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
Vitrea
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea…
Syngo Dynamics
Catalogue number 11708404, listed by Siemens Healthineers AG, Germany, under Automated Radiological Image Processing Software. 8 manufacturers in China are registered for this product code.
EzDent Web
EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and…
ZIRKONZAHN.Implant-Planner Practice Incl. Bone & Tooth Segmentation
Zirkonzahn.Implant-Planner Practice incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12…
Change Healthcare Enterprise Imaging Network Viewer
8 catalogue numbers from 1.0.0, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
NovaPACS
A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities.