Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

Show Filters

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
OtrhoVision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, 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
v2.1
In Commercial Distribution

  • 08800019700081 ()


  • 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
v2.3
In Commercial Distribution

  • 08800019700074 ()


  • 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
v4.3
In Commercial Distribution

  • 08800019700067 ()


  • 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
v2.2
In Commercial Distribution

  • 08800019700050 ()


  • General-purpose dental x-ray system application software
Ez3D Plus 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 Plus 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
v1.2
In Commercial Distribution

  • 08800019700036 ()


  • General-purpose dental x-ray system application software
OtrhoVision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, 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
v2.0
In Commercial Distribution

  • 08800019700029 ()


  • 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
v4.1
In Commercial Distribution

  • 08800019700012 ()


  • 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
v2.1
In Commercial Distribution

  • 08800019700005 ()


  • General-purpose dental x-ray system application software
XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. XmaruView V1 performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Rayence Co., Ltd.
XmaruView V1
In Commercial Distribution

  • 08800018600610 ()


  • Basic diagnostic x-ray system application software
Xmaru Chiroview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Chiroview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Chiroview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Rayence Co., Ltd.
Xmaru Chiroview
In Commercial Distribution

  • 08800018600603 ()


  • Basic diagnostic x-ray system application software
Xmaru Podview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Podview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Podview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Rayence Co., Ltd.
Xmaru Podview
In Commercial Distribution

  • 08800018600597 ()


  • Basic diagnostic x-ray system application software
Xmaru Pro software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, measurements, automated measurement of bone age from a child's hand X-ray, and function to assist the image reading by detecting abnormal areas on the chest X-ray. Xmaru Pro is complying with DICOM standards to assure optimum communications between network systems. (not approved for mammography) Xmaru Pro offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals.
Rayence Co., Ltd.
Xmaru Pro
In Commercial Distribution

  • 08800018600580 ()


  • Basic diagnostic x-ray system application software
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.  It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.  
Rayence Co., Ltd.
ClearON Mobile
In Commercial Distribution

  • 08800018600573 ()


  • Basic diagnostic x-ray system application software
Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.
Rayence Co., Ltd.
Xmaru PACS
In Commercial Distribution

  • 08800018600429 ()


  • Basic diagnostic x-ray system application software
XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management
Rayence Co., Ltd.
XmaruView V1
In Commercial Distribution

  • 08800018600399 ()


  • Basic diagnostic x-ray system application software
Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.3
In Commercial Distribution

  • B816VNC2P30 ()
N/A

  • CT system application software
Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.1.0
In Commercial Distribution

  • B816VNC2P10 ()
N/A

  • CT system application software
EVA SELECT SIZE 2 SENSOR
ImageWorks
9992412205
In Commercial Distribution

  • D83399924122050 ()
9992412205

  • General-purpose dental x-ray system application software
EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution

  • D83399924121050 ()
9992412105

  • General-purpose dental x-ray system application software
Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
Medos International Sàrl
91-4205US
Not in Commercial Distribution

  • 10886704064947 ()
  • 10886704071426 ()
914205US

  • Infusion pump programmer
No Description
EOS IMAGING
1.10
In Commercial Distribution

  • 03663999000153 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation
EOS IMAGING
Workstation 1.8
In Commercial Distribution

  • 03663999000047 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation
EOS IMAGING
Workstation 1.6
In Commercial Distribution

  • 03663999000023 ()


  • Basic diagnostic x-ray system application software
Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
HDX WILL CORP.
Will3D
In Commercial Distribution

  • 08800005200298 ()


  • General-purpose dental x-ray system application software
WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions
HDX WILL CORP.
WillCeph
In Commercial Distribution

  • 08800005200168 ()


  • General-purpose dental x-ray system application software
VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software
No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution

  • E247E72000 ()


  • General-purpose dental x-ray system application software
No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution

  • B745VASCUCAPA2 ()


  • CT system application software
No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution

  • B745ELUCIDVIVOA3 ()


  • CT system application software
No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution

  • B745A40 ()


  • CT system application software
SnapShot Freeze Medical Device
GE MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00195278865335 ()
5963072

  • CT system application software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936889 ()


  • Patient general health self-management software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936872 ()


  • Patient general health self-management software
No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00840682142601 ()


  • CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682146586 ()


  • CT system application software
< 1 ... 172 173 174 175 176 ... 200 >