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510(k) K180516

EchoS by Echolight S.P.A — Product Code MUA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2018
Date Received
February 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Sonometer
Device Class
Class II
Regulation Number
892.1180
Review Panel
RA
Submission Type

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

Other clearances by Echolight S.P.A

  • K212851 — EchoSK and EchoSGyn modules for EchoS Family devices (March 16, 2022)
  • K202514 — EchoS Family (February 25, 2021)

Other clearances for product code MUA

  • K211350 — Bindex BI-2 (April 29, 2022)
  • K202514 — EchoS Family (February 25, 2021)
  • K161919 — UltraScan 650 (April 5, 2017)
  • K161971 — Bindex BI-2 (January 9, 2017)
  • K152020 — Bindex BI-100 (May 13, 2016)
  • K123238 — ACHILLES (February 25, 2013)
  • K110646 — BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (October 12, 2011)
  • K103633 — ACHILLES (May 11, 2011)