(127 days)
The Sonicath Ultra™ Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Not Found
This is a 510(k) premarket notification letter for the Sonicath Ultra Imaging Catheter. The document itself does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications. It merely states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need access to the full 510(k) submission, which typically includes the detailed testing and performance data.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.