(11 days)
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.
The provided document is a 510(k) summary for the TERASON™ Ultrasound System with Continuous Wave (CW) Doppler. It outlines the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.
§ 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.