Diagnocat software is a radiological, automated, concurrent read computer-assisted detectionsoftware intended to aid in the detection of periapical radiolucency on permanent teethcaptured on maxillofacial Cone Beam CT images, only in patients where a dentalprofessional determined such images to be necessary to evaluate possible dentalabnormalities and where the dental professional has the appropriate knowledge and trainingto interpret and assess maxillofacial Cone Beam CT images. The device provides additionalaid for the dental professional to use in their identification of periapical radiolucency. Thedevice is not intended as a replacement for a complete dental professional’s review or theirclinical judgment that considers other relevant information from the patient or other imagesor patient history. The system is to be used by professionally trained and licensed dentalprofessionals.Diagnocat is indicated for use by dental professionals for the second-read of CBCTradiographs of permanent teeth in patients 22 years of age or older.
An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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