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SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data. SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.

SOTA Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any PC with an active internet connection. SOTA Cloud Imaging's single page application design makes the inbrowser imaging experience fast, familiar, and simple to operate. SOTA Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. With SOTA Cloud Imaging, you can use digital dental imaging devices in a manner consistent with your existing imaging solutions, and bridge patient information either from your existing client-server-based practice management software or modern cloud-based practice management software. SOTA Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. SOTA Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using SOTA Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files. SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras. SOTA Cloud Imaging is imaging software designed for use in dentistry. The main SOTA Cloud Imaging software functionality includes image acquisition, organization, and annotation. SOTA Cloud Imaging is used by dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images. SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing, The software operates upon standard PC hardware and displays images on the PC's connected display/monitor. SOTA Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient.

Clio Prime and Clio Pedo are USB-driven digital sensors designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional Clio Prime or Clio Pedo procedures and other diagnostic aides for confirmation. Clio Pedo is a smaller version of Clio Prime and is for pediatric use. The Clio Prime and Clio Pedo design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Clio Prime or Clio Pedo is positioned in the patient's mouth in the same manner as intra-oral film is positioned. Each of Clio Prime and Clio Pedo has a CMOS x-ray imager that creates a digital imaqe from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Clio Prime or Clio Pedo through the standard USB port. Image analysis software is not part of the submission. For Clio Prime or Clio Pedo to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings.