Bone Sonometer
Regulation 892.1180
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in MUA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bone Index Finland , Ltd. | 3 | 0 |
| Echolight S.P.A | 2 | 0 |
| GE Healthcare, LLC | 0 | 2 |
| Ge Medical Systems China Co., Ltd. | 2 | 0 |
| Beam-Med, Ltd. | 1 | 0 |
| Cyberlogic, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2022 | K211350 | Bindex BI-2 Bone Index Finland , Ltd., FI | MUA |
| Feb 25, 2021 | K202514 | EchoS Family Echolight S.P.A, IT | MUA |
| Oct 19, 2018 | K180516 | EchoS Echolight S.P.A, IT | MUA |
| Apr 5, 2017 | K161919 | UltraScan 650 Cyberlogic, Inc. | MUA |
| Jan 9, 2017 | K161971 | Bindex BI-2 Bone Index Finland , Ltd., FI | MUA |
| May 13, 2016 | K152020 | Bindex BI-100 Bone Index Finland , Ltd., FI | MUA |
| Feb 25, 2013 | K123238 | ACHILLES Ge Medical Systems China Co., Ltd., CN | MUA |
| Oct 12, 2011 | K110646 | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER Beam-Med, Ltd., IL | MUA |
| May 11, 2011 | K103633 | ACHILLES Ge Medical Systems China Co., Ltd., CN | MUA |
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