(116 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
INFX-8000C, V6.20, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
The provided text describes modifications to an X-ray system (INFX-8000C, V6.20) and its substantial equivalence to a predicate device, rather than a study evaluating an AI-powered medical device against specific clinical acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI device cannot be extracted from this document.
The document primarily focuses on:
- Changes made to the device (flat panel detectors and C-arm support assembly).
- Compliance with regulatory standards and previous clearances.
- Confirmation that the modifications do not change the indications for use or raise new questions of substantial equivalence.
It does not contain information about an AI device or its performance study.
§ 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.