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510(k) Data Aggregation
K Number
K063107Device Name
3DNET SUITE
Manufacturer
BIOTRONICS3D, LTD.
Date Cleared
2006-10-27
(16 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BIOTRONICS3D, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.
The 3Dnet Suite provides several levels of functionality to the user:
- basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc.
- tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc.
- Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, targeted measurement and visualization, including colon screening which is indented for the screening of patients for colonic polyps, tumors and other lesions using tomographic colonography.
Device Description
The 3Dnet Suite is a software device for evaluating scanned images of selected human organ. The basic visualization module of 3Dnet Suite is Examiner.
The Examiner allows the processing, review, analysis, communication and media interchange of multi dimensional digital images acquired from a variety of imaging devices.
It provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The 3Dnet user interface follows typical clinical workflow patterns to process, review and analyze digital images including:
- Retrieve image data over the network via DICOM
- Select images for closer examination from a gallery of 2D and 3D views
- Interactively manipulate an image in real time to visualize anatomy and pathology
- Annotate, tag, measure and record selected views
- Output selected views to DICOM and JPEG files or expert views to another DICOM device.
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