(30 days)
The Spectris Solaris MR Injection System is a syringe-based fluid delivery system for the delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast media into a patient's vascular system for diagnostic imaging. Only trained healthcare professionals are intended to operate this device.
syringe-based fluid delivery system
This document is a 510(k) premarket notification approval letter for the Medrad Spectris Solaris Injector System. It does not contain information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes for training/testing, or expert qualifications.
The letter explicitly states that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices. This means that the manufacturer presented evidence to the FDA demonstrating that their device is as safe and effective as a device already on the market. The FDA approves the device based on this substantial equivalence, but the approval letter itself does not include the detailed study or performance data.
Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report or a summary of performance data.
§ 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.