21 CFR 884.2225 - Obstetric-gynecologic ultrasonic imager.

§ 884.2225 Obstetric-gynecologic ultrasonic imager.

(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).

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 884 after this date.

  • 2018-06-05; vol. 83 # 108 - Tuesday, June 5, 2018
    1. 83 FR 25910 - Medical Devices; Exemptions From Premarket Notification: Class II Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective June 5, 2018.
      21 CFR Parts 862, 866, 876, 880, and 884