21 CFR § 892.1570 - Diagnostic ultrasonic transducer.

---
identifier: "/us/cfr/t21/s892.1570"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1570 - Diagnostic ultrasonic transducer."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1570"
section_name: "Diagnostic ultrasonic transducer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY 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: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 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.