StacksVerified U.S. regulatory reference

21 CFR §870.2330

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).