21 C.F.R. § 882.1240
Echoencephalograph.
Cite as 21 C.F.R. § 882.1240 (2026)
(a)
Identification.
An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.
(b)
Classification.
Class II (performance standards).