(101 days)
A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.
Collimator (manual drive) – a beam limiting device
This document is an FDA 510(k) clearance letter for a Collimator (manual drive) and does not contain information about acceptance criteria or a study proving its performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.