(172 days)
These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone supine position. Not for mammographic use.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Mobivision Digital Mobile X-Ray Systems (various models)". It confirms the device's substantial equivalence to predicate devices and outlines regulatory requirements.
However, this document does not contain any information about acceptance criteria, study details, device performance, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on 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.