(22 days)
The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.
The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.
The Arcadis Orbic is a mobile x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, CCD camera, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitors, and user interface. The system is equipped with a footswitch and a hand switch for radiation release in the five modes of operation: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping.
The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.
The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.
This document is a 510(k) summary for the Arcadis Orbic mobile X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance against acceptance criteria in the same way a clinical trial for a new drug might. The focus here is on showing that the new device has the same intended use and similar technological characteristics to previously cleared devices, and does not raise new questions of safety and effectiveness.
Therefore, I cannot populate the requested table and sections based on the provided text, as this information is not present.
§ 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.