21 C.F.R. § 870.2330
Echocardiograph.
Cite as 21 C.F.R. § 870.2330 (2026)
(a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. (b) Classification. Class II (performance standards).