FDA 510(k) Applications for Medical Device Product Code "MUA"
(Bone Sonometer)

FDA 510(k) Number Applicant Device Name Decision Date
K110646 BEAM-MED LTD BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER 10/12/2011
K211350 Bone Index Finland Ltd. Bindex BI-2 04/29/2022
K152020 BONE INDEX FINLAND, LTD. Bindex BI-100 05/13/2016
K161971 BONE INDEX FINLAND, LTD. Bindex BI-2 01/09/2017
K161919 CyberLogic, Inc. UltraScan 650 04/05/2017
K202514 Echolight S.p.A. EchoS Family 02/25/2021
K180516 Echolight Spa EchoS 10/19/2018
K103633 GE MEDICAL SYSTEMS CHINA CO., LTD. ACHILLES 05/11/2011
K123238 GE MEDICAL SYSTEMS CHINA CO., LTD. ACHILLES 02/25/2013


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