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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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
Product CodeMUA
Regulation Number 892.1180
Device Class 2


Premarket Reviews
ManufacturerDecision
BONE INDEX FINLAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONE INDEX FINLAND, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CYBERLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT SPA
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Oct-10-2019
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