(20 days)
The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.
Not Found
This document is a 510(k) clearance letter from the FDA for the "XRE Collimator with Spectral Filter" and an "Indications for Use Statement". It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods.
Therefore, I cannot provide the requested information based on the input text. The provided text only confirms that the device has received FDA clearance for marketing based on substantial equivalence to a predicate device.
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.