[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR892.1550]

[Page 539]
 
                        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. 892.1550  Ultrasonic pulsed doppler imaging system.

    (a) Identification. An ultrasonic pulsed doppler imaging system is a 
device that combines the features of continuous wave doppler-effect 
technology with pulsed-echo effect technology and is intended to 
determine stationary body tissue characteristics, such as depth or 
location of tissue interfaces or dynamic tissue characteristics such as 
velocity of blood or tissue motion. This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.