(71 days)
The 4R and 5 mobile x-ray unit with image intensifier system has been designed for diagnosis, suitable for x-ray and radioscopy, and radiography dedicated to:
- Traumatology .
- Paediatrics
- Interventional radiology
- Peace maker implantation
- Operating theater
- Intensive care .
- Respiratory system ●
- Skeleton .
This device does not foresee any interaction with medicine, while the possibility of an interface with some devices like VCR or THERMAL PRINTER is foreseen.
C-Quest 4R and 5 mobile x-ray unit with image intensifier system
The provided document is a 510(k) premarket notification letter from the FDA for a device called "C-Quest 4R and C-Quest 5." This document grants market clearance based on substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study demonstrating the device meets acceptance criteria.
The 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, focusing on indications for use and safety/effectiveness concerns addressed through general controls and potentially special controls for Class II devices. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, I cannot extract the requested information from the provided text. The document is essentially an FDA clearance letter, not a study report.
§ 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.