---
kind: "section"
citation: "21 C.F.R. § 892.1180"
title: "21"
number: "892.1180"
heading: "Bone sonometer."
url: "https://uscodex.org/cfr/21/892.1180"
---

# §892.1180. Bone sonometer.

- (a) **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.
- (b) **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)](/cfr/21/892.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[73 FR 40969, July 17, 2008]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

### Amendments

[73 FR 40969, July 17, 2008]