(211 days)
DX3000 is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatic and adult patients using intraoral film or digital sensors
DX-3000 Portable X-Ray System
There is no information in the provided document about acceptance criteria, device performance, test set sample size, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, training set sample size, or how ground truth for the training set was established.
The document is an FDA 510(k) clearance letter for a dental X-ray system, confirming its substantial equivalence to previously marketed devices. It does not contain efficacy study details.
§ 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.