(129 days)
The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.
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This document does not contain the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details.
The provided text is an FDA 510(k) clearance letter for the ADX4000W Portable X-ray System. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements. It specifies the "Indications for Use" but does not include data from performance studies or acceptance criteria tables.
§ 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.