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
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
VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software
Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software
Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution

  • E247E7200A0 ()


  • 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
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000337 ()


  • Basic diagnostic x-ray system application software
No Description
EOS IMAGING
1.0
Not in Commercial Distribution

  • 03663999000290 ()


  • Basic diagnostic x-ray system application software
No Description
EOS IMAGING
1.10
In Commercial Distribution

  • 03663999000153 ()


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

  • 03663999000054 ()


  • 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 software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • 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
The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X URS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue
No Description
Advanced Bionics, LLC
AB-6500
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
CI-6101
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative
This Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
MULTIRAD NET
In Commercial Distribution

  • 08436046001923 ()


  • Stationary basic diagnostic x-ray system, analogue
The SEDECAL X BRS (BRX) Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SEDECAL X BRS (BRX)
In Commercial Distribution

  • 08436046001909 ()


  • Stationary basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-8.0-APR
In Commercial Distribution

  • 08436046001855 ()


  • Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-4.0-APR
In Commercial Distribution

  • 08436046001848 ()


  • Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-8.0
In Commercial Distribution

  • 08436046001831 ()


  • Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-4.0
In Commercial Distribution

  • 08436046001824 ()


  • Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-8.0
In Commercial Distribution

  • 08436046001794 ()


  • Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-4.0
In Commercial Distribution

  • 08436046001787 ()


  • Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-2.0
In Commercial Distribution

  • 08436046001770 ()


  • Portable basic diagnostic x-ray system, analogue
The SEDECAL X (URS) Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X (URS)
In Commercial Distribution

  • 08436046000933 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC50S
In Commercial Distribution

  • 08800011121914 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC32S
In Commercial Distribution

  • 08800011121891 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV
DRGEM Corporation
GXR-EC20S
In Commercial Distribution

  • 08800011121877 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-EC40S
In Commercial Distribution

  • 08800011121792 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-EC25S
In Commercial Distribution

  • 08800011121778 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-E40S
In Commercial Distribution

  • 08800011121679 ()


  • Stationary basic diagnostic x-ray system, analogue
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
DRGEM Corporation
GXR-E25S
In Commercial Distribution

  • 08800011121655 ()


  • Stationary basic diagnostic x-ray system, analogue
100-240V~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-U40S
In Commercial Distribution

  • 08800011121631 ()


  • Stationary basic diagnostic x-ray system, analogue
< 1 ... 93 94 95 96 97 ... 134 >