21 C.F.R. § 892.1570

Diagnostic ultrasonic transducer.

Last amended: 2016Year: 2026Length: 70 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 892.1570 (2026)

(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container. (b) Classification. Class II.
21 C.F.R. § 892.1570: Diagnostic ultrasonic transducer. | Justis AI