What is FDA product code MUA?

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

Radiology › DiagnosticBone Sonometer

Achilles Expii

Name: Achilles Expii
Brand: Achilles Expii

The Achilles EXPII is a bone ultrasonometer that measures ultrasound variables at the heel bone, or calcaneus. It uses these measurements to calculate a Stiffness Index for assessing…

Registry build 21.09.26

The Achilles EXPII is a bone ultrasonometer that measures ultrasound variables at the heel bone, or calcaneus. It uses these measurements to calculate a Stiffness Index for assessing osteoporotic fracture risk in postmenopausal women.

The Stiffness Index can also be used to follow bone changes over time. Its results contribute to a physician’s skeletal assessment alongside other clinical risk factors.

Listed Item

Bone Ultrasonometer, Achilles

T-Score Reporting

Stiffness Index results are expressed as T-scores to assist physicians in diagnosing osteoporosis. The score provides a standardized way to interpret the device’s heel ultrasound measurement within the broader clinical assessment.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code MUA
Manufacturer	City	Province	Registered as	Device types
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Achilles Expii
Listed by	GE Medical Systems (China) Co., Ltd., China
FDA product code	MUA
Device type	Bone Sonometer
Device class	Class 2
Regulation	21 CFR 892.1180
Establishment	Contract manufacturer, Specification developer, Manufacturer
510(k)	K103633
Record published	2016-06-27
Record revised	2025-05-26 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature 18 to 27 °C; Storage environment humidity 20 to 80 % RH
Distribution end date	2022-06-30

Catalogue Numbers

Catalogue numbers for Achilles Expii
Catalogue number	Size	Status
v1		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Echolight S.p.a.	Echolight SPA	9
Bindex BI-2 Kit	Bone Index Finland Ltd.	4
Bindex	Bone Index Finland Ltd.	2
BeamMed	BeamMed Ltd.	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K123238	2013-02-25
K103633	2011-05-11

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P010058	2004-03-15	OSTEOSPACE	Medilink
P990035	2001-11-30	SUNLIGHT OMNISENSE 7000S	Beam-Med, Ltd.
P000055	2001-07-17	UBIS 5000 BONE SONOMETER	Diagnostic Systems
P980010	2000-09-19	DTU-ONE ULTRASOUND SCANNER	Osteometer Meditech A/S
P990016	2000-01-07	MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0	Coopersurgical, Inc.
P970017	1999-04-29	HOLOGIC SAHARA CLINICAL BONE SONOMETER	Hologic, Inc.
P970040	1998-06-26	ACHILLES EXPRESS ULTRASONOMETER	Ge Lunar Corp.
P970026	1998-05-29	MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN	Myriad Ultrasound Systems, Ltd.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.