(196 days)
This device is intended to be used in the Angiography in Hospital with the X-ray devices.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-5000 is the same as that of predicate device DAR-2400-15B/30B (K955395).
Consequently, the indications for use of the DAR-5000 are also the same as that of the DAR-2400-15B/30B (K955395), and there are no additional indications.
Not Found
This document is a 510(k) clearance letter for the Shimadzu Medical Systems DAR-5000 angiographic x-ray system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert numbers/qualifications, adjudication), MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.