510(k) K123238

ACHILLES by Ge Medical Systems China Co., Ltd. — Product Code MUA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 25, 2013
Date Received: October 16, 2012
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 Ge Medical Systems China Co., Ltd.

K151063 — Monitor B40 (December 15, 2015)
K142288 — MAC 800 Resting ECG Analysis System (December 3, 2014)
K133576 — MONITOR B40 (February 21, 2014)
K130584 — MONITOR B40 (June 26, 2013)
K122253 — PROCARE MONITOR B20 (March 22, 2013)
K120598 — PROCARE MONITOR B40 (July 19, 2012)
K103633 — ACHILLES (May 11, 2011)
K102256 — GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND (October 5, 2010)
K102113 — GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND (August 12, 2010)
K091374 — GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND (May 26, 2009)

Other clearances for product code MUA

K211350 — Bindex BI-2 (April 29, 2022)
K202514 — EchoS Family (February 25, 2021)
K180516 — EchoS (October 19, 2018)
K161919 — UltraScan 650 (April 5, 2017)
K161971 — Bindex BI-2 (January 9, 2017)
K152020 — Bindex BI-100 (May 13, 2016)
K110646 — BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (October 12, 2011)
K103633 — ACHILLES (May 11, 2011)