(65 days)
Not Found
Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-340A system in K941352. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing. It does not change the acoustic output or doppler sensitivity characteristics of the SSA-340A system.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the device's classification, compliance with performance standards, and a summary of its substantial equivalence to a previously cleared device.
Therefore, I cannot provide the requested table and information based on the provided text.
§ 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.