MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
Device Facts
| Record ID | P970026 |
|---|---|
| Device Name | MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN |
| Applicant | Myriad Ultrasound Systems , Ltd. |
| Product Code | MUA · Radiology |
| Decision Date | May 29, 1998 |
| Decision | APRL |
| Regulation | 21 CFR 892.1180 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.
