(73 days)
The Ceiling Mounted Lateral Positioners Model 6896.002 will be used for cardiac imaging required for electrophysiology and heart catherizations imaging
Ceiling Mounted Lateral Positioner, Model No. 6896.002
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Ceiling Mounted Lateral Positioner, Model No. 6896.002." This letter confirms that the device has been found substantially equivalent to a predicate device.
This document does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate. It typically relies on comparisons of design, materials, indications for use, and performance data from engineering tests, rather than extensive clinical studies with specified acceptance criteria and expert-adjudicated ground truth as would be found in a clinical trial report for an AI/ML medical device.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.