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U.S. Department of Health and Human Services

Product Classification
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Device bone sonometer
Regulation Description Bone sonometer.
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.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMUA
Submission Type 510(k)
Regulation Number 892.1180
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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