(234 days)
EmpowerMR: Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.
Not Found
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "E-Z-EM EmpowerMR Injector System and Fastload MR Syringe Pack." It describes the device's indications for use and states that it has been found substantially equivalent to a predicate device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. Therefore, I cannot generate the detailed response you are looking for based solely on this document.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.