Bone Sonometer

Product Code: MUA

Radiology Diagnostic Ultrasound Devices

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 R

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1180


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as MUA

5393Bone SonometerBone Sonometer.

Total Product Life Cycle (TPLC) Devices

5393Bone SonometerBone Sonometer.

Pre-market Approvals for MUA

P990035THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETERBEAM-MED LTD

Pre-market Notifications for MUA

K211350Bindex BI-2Bone Index Finland Ltd.
K202514EchoS FamilyEcholight S.p.A.
K180516EchoSEcholight Spa
K161971Bindex BI-2BONE INDEX FINLAND, LTD.
K161919UltraScan 650CyberLogic, Inc.
K152020Bindex BI-100BONE INDEX FINLAND, LTD.
K123238ACHILLESGE MEDICAL SYSTEMS CHINA CO., LTD.
K110646BEAMMED SUNLIGHT MINIOMNI BONE SONOMETERBEAM-MED LTD
K103633ACHILLESGE MEDICAL SYSTEMS CHINA CO., LTD.

Global Unique Device Identification Database

07299012704119Bone Sonometer
07290012704109Bone Sonometer
06430065790051Bone Sonometer
06430065790044Bone Sonometer
06430065790037Bone Sonometer
06430065790013Bone Sonometer
06430065790006Bone Sonometer
00840682116978Bone sonometer
08052461860039Bone Sonometer
08052461860022Bone Sonometer
08052461860046Bone Sonometer
06430065790068Bone Sonometer

Maude Adverse Events

ACHILLES EXPRESSGE HANGWEI MEDICAL SYSTEMS CO2011-05-19
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