21 CFR 884.2225
§ 884.2225 Obstetric-gynecologic ultrasonic imager.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.2225, § 884.2225 Obstetric-gynecologic ultrasonic imager, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90798
- Permanent ID
ys:prov:90798@1- SHA-256
01cc89d61da10899b8833569ad3d59655dd804fe094f0070453bf6b3682c40ef
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. An obstetric-gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.