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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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No Description
Raysearch Laboratories AB (Publ)
5.0.3
In Commercial Distribution

  • 07350002010020 ()


  • Radiation therapy software
No Description
Raysearch Laboratories AB (Publ)
6.0
In Commercial Distribution

  • 07350002010013 ()


  • Radiation therapy software
No Description
Elekta Solutions AB
6.2
In Commercial Distribution

  • 07340201500064 ()


  • Radiation therapy software
No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 07340201500033 ()


  • Radiation therapy software
MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software also performs automated contouring of risk organs in certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution

  • 07350097430017 ()


  • Radiation therapy software
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
VERIQA software
In Commercial Distribution

  • EPTWS070031 ()
S070031

  • Radiation therapy software
No Description
Prowess, Inc.
v5.61
Not in Commercial Distribution

  • 00859032007088 ()


  • Radiation therapy software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005823 ()
DSC017-03-ROW

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005809 ()
DSC017-02-ROW

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005793 ()
DSC017-02-US

  • Basic diagnostic x-ray system application software
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