(39 days)
Planmeca ProOne, dental panoramic x-ray imaging system, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.
The Planmeca ProOne is a conventional panoramic x-ray system utilizing the digital imaging method. The tube head assembly and sensor rotates around the patient and takes a dental panoramic image of the patient. The product is a new model, with simple and reliable design, but with all necessary functions included. The computer is linked to the device via Ethernet.
This document is a 510(k) summary for the Planmeca ProOne dental panoramic x-ray system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as it predates current requirements for clinical performance data for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information. The document is primarily concerned with regulatory approval based on the device's similarity to existing, legally marketed devices, rather than detailed performance metrics and clinical study results that would typically be found in more recent submissions for AI-enabled devices.
§ 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.