(30 days)
The Orthophos PLUS DS / PLUS DS Ceph is an extraoral source dental X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The Orthophos PLUS DS / PLUS DS Ceph contains 26 factory installed programs that allow for comprehensive imaging of the entire maxillofacial region. These include panoramic exposures of the teeth, maxillary sinuses and temporal mandibular joints, transverse exposures of the maxillary and mandibular molar, canine and anterior areas, and cephalometric exposures of the skull. This Special 510(k) is being submitted to add the transverse slice imaging programs to the panoramic and cephalometric imaging programs previously described in K972312.
The provided document is a Special 510(k) Summary for Orthophos PLUS DS / PLUS DS Ceph, dated November 5, 2001. This document describes a modification to an existing device, the Orthophos DS / DS Ceph (K972312), by adding transverse slice imaging programs. The basis for substantial equivalence relies on the fact that this added technology is the same as that previously reviewed in another cleared device, the Orthophos 5 / PLUS / CD (K983057).
This document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies.
Instead, it focuses on demonstrating that the modified device (Orthophos PLUS DS / PLUS DS Ceph) is substantially equivalent to a previously cleared predicate device, especially regarding the newly added transverse slice imaging capability which was already cleared in another product. The submission included a "hazard analysis, validation testing, and Declaration of Conformity to Design Controls" to support this claim, but the details of these tests and their results are not provided in this summary.
Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain this information. The document is primarily a regulatory submission for substantial equivalence based on existing cleared technology.
§ 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.