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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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For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.2
In Commercial Distribution

  • 07350092810197 ()


  • Pathology information system
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Manteia Technologies Co.,Ltd.
3.1.0
In Commercial Distribution

  • 06973127400050 ()


  • Radiology DICOM image processing application software
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Manteia Technologies Co.,Ltd.
AccuContour
Not in Commercial Distribution



  • Radiology DICOM image processing application software
It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Manteia Technologies Co.,Ltd.
1.1.0
In Commercial Distribution

  • 16973127400019 ()
  • 06973127400012 ()


  • Radiology DICOM image processing application software
PRODUCT SFTWR MMT-7333WW PERSONAL 15.1A
MEDTRONIC MINIMED, INC.
MMT-7333WW
In Commercial Distribution

  • 00763000984755 ()


  • Self-care monitoring/reporting software
PRODUCT SFTWR MMT-7333WW PERSONAL 14.13A
MEDTRONIC MINIMED, INC.
MMT-7333WW
In Commercial Distribution

  • 00763000424121 ()


  • Self-care monitoring/reporting software
It is used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
MedMind Technology Co., Ltd.
V1
In Commercial Distribution

  • 06975191150008 ()


  • Radiology DICOM image processing application software
Software, TomoApps, Version 5.1.2 Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution

  • M65810604640 ()
NA

  • Linear accelerator system
Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.
TECHNIDATA
TDGenet
In Commercial Distribution

  • 03770027519027 ()


  • Clinical laboratory information system application software
Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes Snap+Corefirst, Compass or Communicator software.
TOBII DYNAVOX LLC
Indi 7
Not in Commercial Distribution

  • 07340074601042 ()
750518

  • Voice synthesizer/digitizer
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