(40 days)
The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the LightLine-M device. The document is a clearance letter from the FDA for a 510(k) submission, confirming the device's substantial equivalence to previously marketed devices. It outlines regulatory requirements but does not include details about specific performance metrics or testing results.
§ 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.