Ez3D-i /E3

Ez3D-i v5.5 is dental imaging software designed for medical professionals to provide diagnostic tools and facilitate treatment planning for maxillofacial radiographic imaging. It processes DICOM compliant images from various sources, employing 3D visualization, 2D analysis, and Multi-Planar Reconstruction to aid in patient communication and precise clinical preparation.

A device identified as Ez3D-i / E3 (K231757) was determined to be substantially equivalent for its indicated uses. This device, specifically Ez3D-i v5.5, is dental imaging software intended for trained medical professionals like radiologists and dentists. It provides diagnostic tools for maxillofacial radiographic imaging by viewing and interpreting DICOM compliant dental radiology images. Its functions include 3D visualization, 2D analysis, and Multi-Planar Reconstruction, along with advanced simulation tools for effective doctor-patient communication and precise treatment planning, processing images from various sources such as CT and panorama equipment.Following this, an administrative correction was issued concerning the prior substantial equivalence determination for Ez3D-i / E3. This update specifically addressed and corrected an incorrect product code previously associated with the device from LLZ to QIH. It was clarified that the device's technical review was not re-evaluated during this administrative change.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific improvements or expanded functionalities does Ez3D-i v5.5 offer compared to earlier versions that warranted its substantial equivalence determination?; Beyond general 'CT and panorama equipment,' what are the precise technical specifications or vendor compatibilities required for optimal image processing by Ez3D-i v5.5?; How do the 'advanced simulation tools' quantitatively improve diagnostic accuracy or patient outcomes compared to traditional 2D imaging methods in maxillofacial radiography?; What quality control mechanisms are in place within Ez3D-i v5.5 to ensure the integrity and diagnostic fidelity of reconstructed 3D images and 2D analyses?; Considering the administrative correction of the product code, what impact, if any, does this have on the regulatory compliance or support for devices previously marketed under the incorrect code?