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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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The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5900-01-300
Not in Commercial Distribution

  • 00817491021885 ()
FG-5900-01-300

  • Implantable glucose monitoring system
Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5700-01-300
Not in Commercial Distribution

  • 00817491021878 ()
FG-5700-01-300

  • Implantable glucose monitoring system
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
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
For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device 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 (3.3) 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 (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.2
In Commercial Distribution

  • 07350092810593 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device 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 (3.3) 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 (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.1
In Commercial Distribution

  • 07350092810524 ()


  • Pathology information system
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
4.0
In Commercial Distribution

  • 07350092810500 ()


  • Pathology information system
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