(34 days)
This device is intended to be used for the radiography in the hospital with X-ray devices. The object of this device is total patient population. As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925). Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indications.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called DAR-8000f. This type of document does not typically contain the detailed technical studies, acceptance criteria, or performance data that would be generated by the manufacturer to demonstrate substantial equivalence.
Instead, a 510(k) clearance primarily focuses on:
- Substantial Equivalence: Demonstrating that a new device is as safe and effective as a legally marketed predicate device.
- Intended Use: Defining how the device is meant to be used.
- Regulatory Classification: Assigning the device to a specific regulatory class.
Therefore, the input document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them. It only verifies that the FDA has reviewed the manufacturer's submission and determined it to be substantially equivalent to a predicate device.
To answer your questions, one would need to access the actual 510(k) submission data provided by the manufacturer to the FDA, which is generally not public information in this level of detail unless specifically released or part of a summary.
In summary, based solely on the provided text, I cannot extract the requested information.
§ 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.