(72 days)
The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.
The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The PANOURA 18S is equipped with an X-ray generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit. While rotating around the patient's teeth and jaw, the PANOURA 18S irradiates X-ray and detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are transferred to an image processing unit and the data are superimposed with appropriate shift value according to the X-ray moving speed from the arm rotation to acquire image.
The Panoura 18S is an extraoral x-ray system, which is a medical device and not an AI/ML algorithm. The provided documentation does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH K093683) by comparing technical, operational, and intended use characteristics, and compliance with recognized consensus or voluntary standards for medical electrical equipment and radiation protection.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and performance studies. The provided text describes a traditional medical device submission, not an AI/ML-driven one.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.