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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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Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.2
Not in Commercial Distribution

  • 03700719700396 ()


  • Radiological PACS software
Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
INTRASENSE
MYRIAN 2.1
Not in Commercial Distribution

  • 03700719700013 ()


  • Radiological PACS software
The Theraview software is used in radiation therapy clinics to acquire Megavoltage (MV) and/ or kiloVoltage (kV) images by means of an imaging device, using one of the Cablon Medical accessories EPID, DAR, eDAR or TBI, and perform image registration (i.e. image matching, tracking) or import match results, in order to accurately set up and position patients for treatment
Cablon Medical B.V.
C01-01-00
In Commercial Distribution

  • 08717953004000 ()
C01-01-00

  • Radiation therapy software
Oncentra External Beam v4.5
Nucletron B.V.
Oncentra External Beam
In Commercial Distribution

  • 08717213038677 ()


  • Radiation therapy software
Oncentra Brachy v4.5
Nucletron B.V.
Oncentra Brachy
In Commercial Distribution

  • 08717213038660 ()


  • Radiation therapy software
Oncentra Prostate v4.2 (including Oncentra Seeds)
Nucletron B.V.
Oncentra Prostate including Oncentra Seeds
In Commercial Distribution

  • 08717213037861 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213020610 ()


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

  • 08800005200144 ()


  • Radiological PACS software
No Description
Ray Co., Ltd
2.2.0.0
In Commercial Distribution

  • 08800003005031 ()


  • CAD/CAM software
Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170538-00
In Commercial Distribution

  • 08717213053717 ()


  • Radiation therapy software
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