21 CFR § 870.2880 - Ultrasonic transducer.

---
identifier: "/us/cfr/t21/s870.2880"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.2880 - Ultrasonic transducer."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.2880"
section_name: "Ultrasonic transducer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---


# 870.2880 Ultrasonic transducer.

(a) *Identification.* An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

(b) *Classification.* Class II (performance standards).