OQQ · Diagnostic Ultrasonic Transducer, Robotic
Radiology · 21 CFR 892.1570 · Class 2
Overview
| Product Code | OQQ |
|---|---|
| Device Name | Diagnostic Ultrasonic Transducer, Robotic |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092164 | TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA | Shenzhen Delicate Electronics Co., Ltd. | May 13, 2010 | SESE |
Top Applicants
- Shenzhen Delicate Electronics Co., Ltd. — 1 clearance
