21 CFR 892.1570 — Transducer, Ultrasonic, Diagnostic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1570
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 409 | 3rd Party |
| MUI | Media, Coupling, Ultrasound | 2 | 32 | 3rd Party |
| OQQ | Diagnostic Ultrasonic Transducer, Robotic | 2 | 1 | 3rd Party |
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | 2 | 4 | 3rd Party |
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | 2 | 7 |
