(443 days)
The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.
The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner. The Oriola Sinuscan 102/Sinusprint device functions by ultrasonic sending pulses of energy and receiving echoes from acoustic interfaces in the manner of an echo sounder. The reflected echoes are converted to an electric signal and concise on the LCD display and/or printed by the printer.
This document is a 510(k) summary for the Oriola Sinuscan 102/Sinusprint device, a pulsed ultrasound scanner intended for the detection of frontal and maxillary sinusitis. It does not contain information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on the device's classification, proprietary name, substantial equivalence, description, intended use, and technological characteristics, as required for a 510(k) submission.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.