21 C.F.R. § 892.1560 Ultrasonic pulsed echo imaging system.
Title 21 - Food and Drugs
(a) Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. (b) Classification. Class II.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1560 Ultrasonic pulsed echo imaging system.
