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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
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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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