(248 days)
The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the R-30H. The document is an FDA 510(k) clearance letter for the R-30H, an angiographic x-ray system. It states that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail any performance studies, acceptance criteria, or specific metrics.
§ 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.