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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Subscribe to: 21 CFR 892.1550
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(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.