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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.

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