[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: 21CFR884.2225]

[Page 452]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart C_Obstetrical and Gynecological Monitoring Devices
 
Sec. 884.2225  Obstetric-gynecologic ultrasonic imager.

    (a) Identification. An obstetric-gynecologic ultrasonic imager is a 
device designed to transmit and receive ultrasonic energy into and from 
a female patient by pulsed echoscopy. This device is used to provide a 
visual representation of some physiological or artificial structure, or 
of a fetus, for diagnostic purposes during a limited period of time. 
This generic type of device may include the following: signal analysis 
and display equipment, electronic interfaces for other equipment, 
patient and equipment supports, coupling gel, and component parts. This 
generic type of device does not include devices used to monitor the 
changes in some physiological condition over long periods of time.
    (b) Classification. Class II (performance standards).