[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1560]

[Page 509]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 892--RADIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 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.