· Dentrix Imaging is an FDA regulated class II medical device designed for viewing existing clinical images acquired via an imaging (PACS) system.
· Dentrix Imaging is intended to be used in combination with other approved medical devices. To ensure Dentrix Imaging does not impair performance, the other approved medical device must be functional and working per the manufacturer's IFU before using in combination with Dentrix Imaging.
· Dentrix Imaging is designed for use in the field of dentistry. Federal law restricts Dentrix Imaging to sales by or on the order of a dentist.
· To effectively use the Dentrix Imaging software, it is strongly recommended that all users obtain dedicated training on the use of Dentrix Imaging software prior to use on any patients.
· Read and understand the Help in its entirety before using the Dentrix Imaging software on patients.
· Use of this software as a diagnostic aid must be used in combination with other diagnostic aids, PACS systems, and clinical experience to form a diagnosis and should not be solely relied upon for diagnosis.
· Do not operate Dentrix Imaging software upon patients if you are feeling ill, fatigued, or if you are experiencing lack of concentration.
· Do not leave any computer/device that is operating Dentrix Imaging software unattended as this can create a security risk to the patient or practice data.
· Contact Dentrix Customer Support you have any questions or comments regarding the Dentrix Imaging software.