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510(k) Data Aggregation
K Number
K063773Device Name
VOLUMETRIC TOMOGRAPHY
Manufacturer
INSTRUMENTARIUM DENTAL INC.
Date Cleared
2007-01-31
(41 days)
Product Code
OAS, MUH
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTARIUM DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Volumetric Tomography is intended to be used for producing crosssectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.
Device Description
The Volumetric Tomography imaging option for Orthopantomograph® OP100 and OP200 product families utilizes Statistical Inversion (SI) that is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object. To reconstruct means producing cross-sectional images from a set of projection images by using computer calculation. Projection image means a radiographic image from a certain angle in which the structures of the object are seen superimposed. Tomographic means viewing an object as a series of thin slices. Projection images are captured with a digital panoramic unit using scanning as the imaging method. Scanning projection images is previously known technique and commonly used for example in digital cephalometric units. Along with the object a set of fiducials are recorded on the projection images to be used for geometry refinement and cross-registration between the reconstructed image set and a separate panoramic scout image. Tomographic images are then reconstructed from the projection images with a computer. For dimensional information for dental implant planning and information about location of impacted teeth all three imaging modalities can be used: projection image set, the panoramic image and the reconstructed image set. The tomographic slice and the slice angle are selectable after reconstruction to ensure the correct positioning of the slice referenced to the anatomy. In addition to the selection of the tomographic slice also the slice angle is user adjustable to ensure the correct position and angle compared to the anatomy.
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