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 Class Implantable

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No Description
Change Healthcare Canada Company
14.2.1
In Commercial Distribution

  • 17540262010060 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
14.2
In Commercial Distribution

  • 17540262010053 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
2.1.1
In Commercial Distribution

  • 17540262010046 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
2.1
In Commercial Distribution

  • 17540262010039 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
2.0
In Commercial Distribution

  • 17540262010022 ()


  • Radiological PACS software
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET,SPECT, Ultrasound &Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation,2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and CT colonoscopy.
SHINA SYSTEMS LTD.
3.2
In Commercial Distribution

  • 07290018235003 ()


  • Radiological PACS software
Unifi® Software is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammmography images as well as other medical images and data.
Hologic, Inc.
Unifi Workspace V1.0
Not in Commercial Distribution

  • 15420045511859 ()


  • Radiological PACS software
Unifi® Software is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammmography images as well as other medical images and data.
Hologic, Inc.
Unifi Workspace V1.0
Not in Commercial Distribution

  • 15420045512634 ()


  • Radiological PACS software
Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Medical USA
3.0
In Commercial Distribution

  • EOLEOLEASPHEREV3P01 ()


  • Radiological PACS software
Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Medical USA
2.3
Not in Commercial Distribution

  • EOLEOLEASPHEREV2P31 ()


  • Radiological PACS software
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