[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: 21CFR892.1570]

[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. 892.1570  Diagnostic ultrasonic transducer.

    (a) Identification. A diagnostic ultrasonic transducer is a device 
made of a piezoelectric material that converts electrical signals into 
acoustic signals and acoustic signals into electrical signals and 
intended for use in diagnostic ultrasonic medical devices. Accessories 
of this generic type of device may include transmission media for 
acoustically coupling the transducer to the body surface, such as 
acoustic gel, paste, or a flexible fluid container.
    (b) Classification. Class II.