21 CFR § 870.2880
Ultrasonic transducer
June 25, 2020
(a) Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.
(b) Classification. Class II (performance standards).