[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: 21CFR870.2330] [Page 321] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 870_CARDIOVASCULAR DEVICES--Table of Contents Subpart C_Cardiovascular Monitoring Devices Sec. 870.2330 Echocardiograph. (a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. (b) Classification. Class II (performance standards).