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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

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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
Absorbable Collagen Membrane (30X40MM) for dental surgery.
SEPTODONT, INC
9627O
In Commercial Distribution

  • 13760140703622 ()
  • 03760140703625 ()


  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
Absorbable Collagen Membrane (20X30MM) for dental surgery
SEPTODONT, INC
9626N
In Commercial Distribution

  • 03760140703618 ()
  • 13760140703615 ()


  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
Absorbable Collagen Membrane (15X20MM) for dental surgery.
SEPTODONT, INC
9625M
In Commercial Distribution

  • 13760140703608 ()
  • 03760140703601 ()


  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
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
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