Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1180](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1180) → MUA — Bone Sonometer

# MUA · Bone Sonometer

_Radiology · 21 CFR 892.1180 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA

## Overview

- **Product Code:** MUA
- **Device Name:** Bone Sonometer
- **Regulation:** [21 CFR 892.1180](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1180)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (17 of 17)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K211350](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K211350.md) | Bindex BI-2 | Bone Index Finland , Ltd. | Apr 29, 2022 | SESE |
| [K202514](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K202514.md) | EchoS Family | Echolight S.P.A | Feb 25, 2021 | SESE |
| [K180516](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K180516.md) | EchoS | Echolight S.P.A | Oct 19, 2018 | SESE |
| [K161919](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K161919.md) | UltraScan 650 | Cyberlogic, Inc. | Apr 5, 2017 | SESE |
| [K161971](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K161971.md) | Bindex BI-2 | Bone Index Finland , Ltd. | Jan 9, 2017 | SESE |
| [K152020](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K152020.md) | Bindex BI-100 | Bone Index Finland , Ltd. | May 13, 2016 | SESE |
| [K123238](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K123238.md) | ACHILLES | Ge Medical Systems China Co., Ltd. | Feb 25, 2013 | SESE |
| [K110646](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K110646.md) | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | Beam-Med, Ltd. | Oct 12, 2011 | SESE |
| [K103633](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/K103633.md) | ACHILLES | Ge Medical Systems China Co., Ltd. | May 11, 2011 | SESE |
| [P010058](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P010058.md) | OSTEOSPACE | Medilink | Mar 15, 2004 | APRL |
| [P000055](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P000055.md) | UBIS 5000 BONE SONOMETER | Diagnostic Medical Systems | Jul 17, 2001 | APRL |
| [P980010](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P980010.md) | DTU-ONE ULTRASOUND SCANNER | Osteometer Meditech A/S | Sep 19, 2000 | APRL |
| [P990035](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P990035.md) | THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER | Beam-Med, Ltd. | Jan 20, 2000 | APRL |
| [P990016](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P990016.md) | MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 | CooperSurgical, Inc. | Jan 7, 2000 | APRL |
| [P970040](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P970040.md) | ACHILLES EXPRESS ULTRASONOMETER | Ge Lunar Corp. | Jun 26, 1998 | APRL |
| [P970026](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P970026.md) | MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN | Myriad Ultrasound Systems , Ltd. | May 29, 1998 | APRL |
| [P970017](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA/P970017.md) | SAHARA CLINICAL BONE SONOMETER | Hologic, Inc. | Mar 12, 1998 | APRL |

## Top Applicants

- Bone Index Finland , Ltd. — 3 clearances
- Beam-Med, Ltd. — 2 clearances
- Echolight S.P.A — 2 clearances
- Ge Medical Systems China Co., Ltd. — 2 clearances
- CooperSurgical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUA)

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