MUA · Bone Sonometer
Radiology · 21 CFR 892.1180 · Class 2
Overview
| Product Code | MUA |
|---|---|
| Device Name | Bone Sonometer |
| Regulation | 21 CFR 892.1180 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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 | Bindex BI-2 | Bone Index Finland , Ltd. | Apr 29, 2022 | SESE |
| K202514 | EchoS Family | Echolight S.P.A | Feb 25, 2021 | SESE |
| K180516 | EchoS | Echolight S.P.A | Oct 19, 2018 | SESE |
| K161919 | UltraScan 650 | Cyberlogic, Inc. | Apr 5, 2017 | SESE |
| K161971 | Bindex BI-2 | Bone Index Finland , Ltd. | Jan 9, 2017 | SESE |
| K152020 | Bindex BI-100 | Bone Index Finland , Ltd. | May 13, 2016 | SESE |
| K123238 | ACHILLES | Ge Medical Systems China Co., Ltd. | Feb 25, 2013 | SESE |
| K110646 | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | Beam-Med, Ltd. | Oct 12, 2011 | SESE |
| K103633 | ACHILLES | Ge Medical Systems China Co., Ltd. | May 11, 2011 | SESE |
| P010058 | OSTEOSPACE | Medilink | Mar 15, 2004 | APRL |
| P000055 | UBIS 5000 BONE SONOMETER | Diagnostic Medical Systems | Jul 17, 2001 | APRL |
| P980010 | DTU-ONE ULTRASOUND SCANNER | Osteometer Meditech A/S | Sep 19, 2000 | APRL |
| P990035 | THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER | Beam-Med, Ltd. | Jan 20, 2000 | APRL |
| P990016 | MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 | CooperSurgical, Inc. | Jan 7, 2000 | APRL |
| P970040 | ACHILLES EXPRESS ULTRASONOMETER | Ge Lunar Corp. | Jun 26, 1998 | APRL |
| P970026 | MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN | Myriad Ultrasound Systems , Ltd. | May 29, 1998 | APRL |
| P970017 | 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
