(15 days)
The digital x-ray sensor system, ImageRAYi, of Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray is a suosimar of Homan oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.
digital x-ray sensor system
This document is a 510(k) premarket notification letter from the FDA to Dentrix Dental Systems, Inc. regarding their ImageRAYi device. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter is a regulatory approval, not a scientific report detailing the clinical validation or performance metrics of the device. It indicates that the device has met the regulatory hurdle of substantial equivalence, which means it is as safe and effective as a legally marketed predicate device. To find the information requested, one would typically need to refer to the 510(k) submission itself, or any associated clinical or performance studies included within that submission, rather than just the FDA's decision letter.
§ 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.