(117 days)
The BBS Revolution system projects ultrasound energy through the lower abdomen of the patient an image of the bladder, which is used to calculate bladder volume non-invasively.
Not Found
This document is a 510(k) clearance letter from the FDA for the dBMEDx, Inc. BBS Revolution device. It does not contain information about acceptance criteria or a study that proves the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.
Therefore, I cannot extract the requested information from the provided text.
§ 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.