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Ultrasound imaging system main unit
Cortex Technology ApS
08
In Commercial Distribution
- 05710188039000 ()
A0390008
- Ultrasound imaging system operator console
No Description
OXOS Medical, Inc.
MC2
In Commercial Distribution
- 00860008892782 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
F1
In Commercial Distribution
- 00860008892706 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution
- 00860008892744 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
K1
In Commercial Distribution
- 00860008892737 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
H1
In Commercial Distribution
- 00860008892713 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
MULTIFUNCTIONAL IMAGING, LLC
v1
In Commercial Distribution
- 00860059002109 ()
- PET system application software
Dental Cloud Imaging Software
Sota Cloud Corp.
1
In Commercial Distribution
- 00860013687632 ()
- General-purpose dental x-ray system application software
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution
- 00852426007022 ()
- CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution
- 00852426007015 ()
- CT system application software
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution
- 00852426007008 ()
- CT system application software
Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution
- 00851159007125 ()
- General-purpose dental x-ray system application software
No Description
OXOS Medical, Inc.
E1
In Commercial Distribution
- 00860001123425 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
C1
In Commercial Distribution
- 00860001123418 ()
- Hand-held basic diagnostic x-ray system, digital
No Description
OXOS Medical, Inc.
M01
In Commercial Distribution
- 00860001123401 ()
- Hand-held basic diagnostic x-ray system, digital
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution
- 00882916000530 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
2.1
In Commercial Distribution
- 00882916000523 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution
- 00882916000516 ()
v1.x and v2.0
- CT system application software
Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution
- 00851067007033 ()
400-1243S
- General-purpose dental x-ray system application software
Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution
- 00851067007026 ()
400-1242S
- General-purpose dental x-ray system application software
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution
- 00861787000306 ()
- General-purpose dental x-ray system application software
No Description
COCHLEAR LIMITED
S428163
In Commercial Distribution
- 09321502033770 ()
S428163
- Hearing implant implantable-component tester, postoperative
Version 1.0
COCHLEAR LIMITED
P1479694
In Commercial Distribution
- 09321502044059 ()
P1479694
- Hearing implant implantable-component tester, postoperative
Cochlear Nucleus Intergrity Test System
COCHLEAR LIMITED
S264916
In Commercial Distribution
- 09321502027809 ()
ITSYS
- Hearing implant implantable-component tester, postoperative
CRYSTAL INTEGRITY TEST SYSTEM
COCHLEAR LIMITED
Z60033
In Commercial Distribution
- 09321502006637 ()
Z60033
- Hearing implant implantable-component tester, postoperative
User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s)
Curetis GmbH
C8 Cockpit
Not in Commercial Distribution
- 04260364750027 ()
60003
- Laboratory instrument/analyser control unit IVD
Gamma Camera Workstation for Acquisition, Reviewing and Processing
MiE medical imaging electronics GmbH
SCINTRON
In Commercial Distribution
- 04260484140050 ()
- Nuclear medicine system operator console, multi-purpose
Nuclear Medicine Workstation for Aquisition, Viewing and Processing
MiE medical imaging electronics GmbH
ECAT Scintron PET
In Commercial Distribution
- 04260484140029 ()
- Nuclear medicine system operator console, multi-purpose
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 standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy.
The software provides a range of features, including:
- 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP).
- 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering.
- Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning.
- Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices.
The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image
acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution
- 08800019700593 ()
- General-purpose dental x-ray system application software
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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
3.5
In Commercial Distribution
- 08800019700531 ()
- General-purpose dental x-ray system application software
Ez3D-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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
EWOO SOFT Co., Ltd
5.5
In Commercial Distribution
- 08800019700401 ()
- General-purpose dental x-ray system application software
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 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software.
EzDent Web provides you with the following functions using patient images in 2D and 3D.
- Manage patient information
- View patient images in 2D/3D using tools for image processing and view function.
- Use high resolution 3D VR to view 3D images in the optimized view for user intent.
- Consult patients using media contents provided for patient consultation.
EWOO SOFT Co., Ltd
v1.2
In Commercial Distribution
- 08800019700395 ()
- General-purpose dental x-ray system application software
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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
3.4
In Commercial Distribution
- 08800019700388 ()
- General-purpose dental x-ray system application software
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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
3.3
In Commercial Distribution
- 08800019700357 ()
- General-purpose dental x-ray system application software
Ez3D-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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
EWOO SOFT Co., Ltd
5.4
In Commercial Distribution
- 08800019700340 ()
- General-purpose dental x-ray system application software
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
EWOO SOFT Co., Ltd
1.3
In Commercial Distribution
- 08800019700319 ()
- General-purpose dental x-ray system application software
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
EWOO SOFT Co., Ltd
1.2
In Commercial Distribution
- 08800019700258 ()
- General-purpose dental x-ray system application software
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 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software.
EzDent Web provides you with the following functions using patient images in 2D and 3D.
- Manage patient information
- View patient images in 2D/3D using tools for image processing and view function.
- Use high resolution 3D VR to view 3D images in the optimized view for user intent.
- Consult patients using media contents provided for patient consultation.
EWOO SOFT Co., Ltd
v1.0
In Commercial Distribution
- 08800019700241 ()
- General-purpose dental x-ray system application software
Ez3D-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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
EWOO SOFT Co., Ltd
v5.3
In Commercial Distribution
- 08800019700234 ()
- General-purpose dental x-ray system application software
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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
v3.2
In Commercial Distribution
- 08800019700227 ()
- General-purpose dental x-ray system application software
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
EWOO SOFT Co., Ltd
1.1
In Commercial Distribution
- 08800019700203 ()
- General-purpose dental x-ray system application software
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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
v3.1
In Commercial Distribution
- 08800019700197 ()
- General-purpose dental x-ray system application software
Smart M Viewer(EzDent-i OEM) is medical 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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Smart M Viewer (EzDent-i OEM) is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
v3.0
In Commercial Distribution
- 08800019700180 ()
- General-purpose dental x-ray system application software
Ez3D-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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
EWOO SOFT Co., Ltd
v5.2
In Commercial Distribution
- 08800019700173 ()
- General-purpose dental x-ray system application software
EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution
- 08800019700159 ()
- General-purpose dental x-ray system application software
EzMobile 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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
v1.1
In Commercial Distribution
- 08800019700142 ()
- General-purpose dental x-ray system application software
Ez3D-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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
EWOO SOFT Co., Ltd
v5.1
In Commercial Distribution
- 08800019700128 ()
- General-purpose dental x-ray system application software
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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
EWOO SOFT Co., Ltd
v3.0
In Commercial Distribution
- 08800019700111 ()
- General-purpose dental x-ray system application software
Ez3D-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 compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
EWOO SOFT Co., Ltd
v5.0
In Commercial Distribution
- 08800019700098 ()
- General-purpose dental x-ray system application software