ACHILLES EXPRESS ULTRASONOMETER
Device Facts
| Record ID | P970040 |
|---|---|
| Device Name | ACHILLES EXPRESS ULTRASONOMETER |
| Applicant | Ge Lunar Corp. |
| Product Code | MUA · Radiology |
| Decision Date | Jun 26, 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.
