MUA — Bone Sonometer Class II
FDA product code MUA covers "Bone Sonometer", a Class II medical device regulated under 21 CFR 892.1180. Submissions are reviewed by the Radiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUA
- Device Class
- Class II
- Regulation Number
- 892.1180
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211350 | bone index finland | Bindex BI-2 | April 29, 2022 |
| K202514 | echolight | EchoS Family | February 25, 2021 |
| K180516 | echolight | EchoS | October 19, 2018 |
| K161919 | cyberlogic | UltraScan 650 | April 5, 2017 |
| K161971 | bone index finland | Bindex BI-2 | January 9, 2017 |
| K152020 | bone index finland | Bindex BI-100 | May 13, 2016 |
| K123238 | ge medical systems china co | ACHILLES | February 25, 2013 |
| K110646 | beam-med | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | October 12, 2011 |
| K103633 | ge medical systems china co | ACHILLES | May 11, 2011 |