21 CFR 892.1550 — System, Imaging, Pulsed Doppler, Ultrasonic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1550
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 1159 | 3rd Party |
| NCS | System, Imaging, Holography, Acoustic | 2 | 3 | |
| PSV | Ultrasound Bronchoscope | 2 | 3 |
