(153 days)
The Planmeca Dimax Digital Panoramic X-ray Unit 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. This device is a multimode imaging system, which combines following imaging procedures:
- Narrow beam tomography (= panoramic mode)
- Cephalometric radiography
The use of the device is allowed only under supervision of a dentist.
The Planmeca Dimax Digital Panoramic X-ray Unit is an extraoral source X-ray system.
This letter primarily serves as an FDA clearance for the Planmeca Dimax Digital X-ray device and provides general regulatory information. It does not include details about specific acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval letter, not a technical report or study summary that would contain performance data and acceptance criteria.
§ 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.