(15 days)
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images for image diagnosis. This system is intended for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, and lower limb blood vessels.
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images.
The provided text is a 510(k) summary for the Toshiba Digital Radiography System, Model DFP-8000D. It describes the device, its intended use, and its technological characteristics in comparison to a predicate device.
However, the provided document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes for training or testing, ground truth establishment, expert qualifications, or adjudication methods.
The document is a regulatory submission summary that indicates the device received substantial equivalence to a predicate device, which allows it to be marketed. This type of submission typically focuses on demonstrating similarity to an already cleared device, rather than providing detailed performance studies with acceptance criteria as one would find for a novel device or a device requiring clinical trials.
Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided text. The prompt asks for specific details about a study and acceptance criteria that are not present in this regulatory summary.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.