(30 days)
The OrthoXP is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
The OrthoXP (510k submission device) is not intended for mammography.
OrthoXP digital radiographic system
This appears to be a 510(k) clearance letter for the OrthoXP digital radiographic system, which details its indications for use but does not contain information about acceptance criteria or the specific studies demonstrating performance against such criteria. The letter confirms the device's substantial equivalence to a predicate device but does not include the detailed performance study information typically found in a 510(k) summary or the full submission.
Therefore,Based on the provided document, the requested information regarding acceptance criteria and the study proving the device meets those criteria is not available. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a legally marketed predicate device but does not detail the specific performance studies that led to this determination.
To answer your questions, one would typically need access to the 510(k) summary or the full 510(k) submission, which would contain the performance data and acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.