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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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Diagnostic web DICOM viewer
NEOLOGICA SRL
9.1.2
Not in Commercial Distribution

  • B383REV090102000 ()


  • Radiological PACS software
Diagnostic web DICOM viewer
NEOLOGICA SRL
10.0.2
In Commercial Distribution

  • B383REV100002000 ()


  • Radiological PACS software
Diagnostic web DICOM viewer
NEOLOGICA SRL
10.0.1
Not in Commercial Distribution

  • B383REV100001000 ()


  • Radiological PACS software
Diagnostic web DICOM viewer
NEOLOGICA SRL
9.2.4
Not in Commercial Distribution

  • B383REV090204000 ()


  • Radiological PACS software
Diagnostic web DICOM viewer
NEOLOGICA SRL
9.2.2
Not in Commercial Distribution

  • B383REV090202000 ()


  • Radiological PACS software
Diagnostic web DICOM viewer
NEOLOGICA SRL
9.2.1
Not in Commercial Distribution

  • B383REV090201000 ()


  • Radiological PACS software
LIFESYS PACS v2
LIFETRACK MEDICAL SYSTEMS INC.
2
In Commercial Distribution

  • B581LIFESYSPACSV20 ()


  • Radiological PACS software
No Description
SIRIS MEDICAL, INC.
IRT100
In Commercial Distribution

  • B244IRT1000 ()
IRT100

  • Radiation therapy software
Vessel Analysis is a post-processing add-on module for ORS Visual that enables radiologists, cardiologists, vascular surgeons, and interventionalists to quickly and confidently evaluate CT angiographic studies. Vessel Analysis provides stenosis calculations, aneurysm quantification, and stent and stent-graft planning of the aorta, carotid, and renal arteries in an easy-to-use, intuitive screen that can simplify the clinical task of planning endovascular procedures. Advanced functionality such as automated vessel finding acts as a baseline for accurate vessel measurements and permits rapid segmentation of vessels. ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware.
Object Research Systems (ORS) Inc
ORS-VISU-VA01
In Commercial Distribution

  • B332VIVA0100 ()


  • Radiological PACS software
ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. Available functions include DICOM communication, display of 2D images in orthogonal and oblique planes, computation and display of rendered 3D images and maximum intensity projections (MIPs), and 2D and 3D image measurements. The user interface follows typical clinical workflow patterns that include searching for patient data, reviewing and analyzing digital images, and reporting findings. The user controls these functions with normal mouse-click conventions, a system of context-based tools, and on-screen prompts. A standard layout for image display, navigation, and information is used throughout the application. ORS Visual also offers users two separate add-on modules to address specific vascular clinical functionalities: Vessel Analysis, an add-on solution for vascular analysis and stent-graft planning of CTA studies, and Autoplaque, a cardiac plaque and lesion quantification tool.
Object Research Systems (ORS) Inc
ORS-VISU-0105
In Commercial Distribution

  • B332VISU0105 ()


  • Radiological PACS software
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