21 CFR § 892.1550 - Ultrasonic pulsed doppler imaging system.

---
identifier: "/us/cfr/t21/s892.1550"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1550 - Ultrasonic pulsed doppler imaging system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1550"
section_name: "Ultrasonic pulsed doppler imaging system."
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"
---


# 892.1550 Ultrasonic pulsed doppler imaging system.

(a) *Identification.* An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) *Classification.* Class II.