(175 days)
No change from existing SONOS 2500 platform reviewed during 510(k) 934041
This modification allows for transmission of an ultrasound signal at one frequency and receipt of the returning echo at a different frequency. A minor system modification is made to detect these harmonic echoes. New transducer, component modifications to two circuit boards and SW to recognize/drive the new transducer.
The provided text does not contain information on acceptance criteria or a study proving device performance against such criteria. The document describes a 510(k) summary for a modification to an ultrasound imaging system (Sonos 2500) to enable harmonic imaging. It focuses on the technical aspects of the modification and its predicate devices, not on clinical performance studies or specific performance metrics.
Therefore, I cannot fulfill the request to build the table and provide the details about a study, as this information is absent in the input.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.