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510(k) Data Aggregation
K Number
K160666Device Name
Dentiq3D
Manufacturer
Date Cleared
2016-10-05
(210 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
3D INDUSTRIAL IMAGING CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
Device Description
Dentiq3D is a dental image software platform for the 3D visualization and analysis of volume data. Dentig3D is optimized for analyzing volume data from CT scan and enables users to examine volume data through 3D visualization, 2D analysis, and various MPR functions to manipulate CT images. The functions include canal tracing, implant simulation, volume segmentation and airway measurement.
The following are the major functions of Dentiq3D.
- Visualizes CT volume data
- Supports various types of data
- Measures 3D object
- Analyzes and filters volume data
- Publishes various forms of report
- 3D visualization by using GPU
- Loads and saves project files
- Restores (Undo) or repeats (Redo) tasks based on operation history
- Supports a user-friendly interface
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