(305 days)
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX device does not contain information about acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC or standalone).
This document is primarily a letter from the FDA confirming the substantial equivalence of the SOPIX device to existing legally marketed devices, along with the device's indications for use. It details regulatory information rather than a performance study.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 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.