# Bone Sonometer
> **Product code: MUA** · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1180
## Classification
- **FDA Product Code:** MUA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 892.1180
- **Review panel:** RA
- **Medical specialty:** Radiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.  Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers

## Market data
- **Cleared 510(k) submissions:** 9
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=MUA)
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