(29 days)
The AN6255 and AN6265 are digital X-ray general radiography systems intended for use by qualified/trained doctor or technician and are designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremitties and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from these systems are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOMPACS) network, clinical review station or to a film printer.
Digital Radiology Systems
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary and FDA clearance letter for the Analogic AN6255 and AN6265 Digital Radiology Systems, establishing substantial equivalence to a predicate device. It details administrative information like the submitter's name, device name, and indications for use, but lacks any performance study data.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and studies as it is not present in the provided 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.