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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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SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.4.0
In Commercial Distribution

SURGICALPREVIEW240

  • Vascular modelling software
Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.2.0
In Commercial Distribution

SURGICALPREVIEW220

  • Vascular modelling software
SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
2.1.0
In Commercial Distribution

  • B642SURGICALPREVIEW2100 ()
SURGICALPREVIEW210

  • Vascular modelling software
SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.2.0
In Commercial Distribution

  • B642SURGICALPREVIEW1200 ()
SURGICALPREVIEW120

  • Vascular modelling software
SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.1.0
In Commercial Distribution

  • B642SURGICALPREVIEW1100 ()
SURGICALPREVIEW110

  • Vascular modelling software
SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview enables assessment and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. It provides techniques to assess the feasibility of endovascular procedures. SurgicalPreview also allows for the ability to simulate the placement and deployment of neurointerventional devices. SurgicalPreview can reconstruct 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide diagnostic information nor does it determine recommended medical care. The clinician receiving the images from the software retains the responsibility for interpreting and validating all information and making all treatment decisions using standard practices.
ENDOVANTAGE LLC
1.0
In Commercial Distribution

  • B642SURGICALPREVIEW100 ()
SURGICALPREVIEW10

  • Vascular modelling software
No Description
Thinking Systems Corporation
06
In Commercial Distribution

  • G01900 ()


  • Radiological PACS software
AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements, • Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.
Ai Metrics, LLC
1
In Commercial Distribution

  • G090AIM11 ()
AIM1

  • Radiological PACS software
Sidexis 4 (Update) 4.4
SIRONA Dental Systems GmbH
6775592
In Commercial Distribution

  • E27667755921 ()


  • Radiological PACS software
Sidexis 4 (Upgrade) 4.4
SIRONA Dental Systems GmbH
6775584
In Commercial Distribution

  • E27667755841 ()


  • Radiological PACS software
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