Title 21 Part 892 → Subpart B → §892.1560

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1560

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1560

e-CFR data is current as of September 18, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1560

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§892.1560   Ultrasonic pulsed echo imaging system.

(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.