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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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CaloPix - 03760408001005

CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
TRIBUN HEALTH
6.1.0 IVDUS
In Commercial Distribution

  • 03760408001005 ()


  • Pathology information system

RT-Mind-AI - 06975191150008

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

AccuContour - 06973127400050

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

AccuContour - 06973127400029

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

AccuContour - 06973127400012

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

Sectra Digital Pathology Module - 07350092810593

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

Sectra Digital Pathology Module - 07350092810524

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

Sectra Digital Pathology Module - 07350092810500

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

Sectra Digital Pathology Module - 07350092810487

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
3.4
In Commercial Distribution

  • 07350092810487 ()


  • Pathology information system

Sectra Digital Pathology Module - 07350092810456

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
3.3
In Commercial Distribution

  • 07350092810456 ()


  • Pathology information system
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