Data / Medical devices / Bone Sonometer
Bone Sonometer (MUA): 5 FDA-registered makers in 5 countries
5 establishments in 5 countries are registered with the FDA to make Bone Sonometer (product code MUA, Class 2, 21 CFR 892.1180). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on April 29, 2022, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MUA
- Device class
- 2
- Regulation
- 892.1180
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Italy | 1 |
| China | 1 |
| Finland | 1 |
| Israel | 1 |
| United States | 1 |
Makers of Bone Sonometer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Echolight S.P.A. | Lecce, Italy | Manufacturer | 2 | February 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 2 | February 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| Bone Index Finland Ltd. | Kuopio Pohjois-Savo, Finland | Exporter to the US, Manufacturer | 1 | April 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| BeamMed Ltd. | Petah Tikva Central, Israel | Manufacturer | 1 | October 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cyberlogic, Inc. | Brooklyn, NY, United States | Manufacturer | 1 | April 5, 2017 | 0 | 0 | 0 | api.fda.gov |
Updated April 29, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.