(88 days)
The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.
Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Orthopantomograph® OP30, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It confirms FDA clearance but does not include details on specific performance metrics, studies, sample sizes, or ground truth establishment.
§ 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.