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

Bindex BI-2 Kit

Name: Bindex BI-2 Kit
Brand: Bindex BI-2 Kit

Bindex BI-2 measures apparent cortical bone thickness at the proximal tibia and calculates a Density Index estimating hip bone mineral density. Clinicians use it alongside other risk…

Registry build 21.09.26

Bindex BI-2 measures apparent cortical bone thickness at the proximal tibia and calculates a Density Index estimating hip bone mineral density. Clinicians use it alongside other risk factors and patient characteristics to assist osteoporosis assessment and fracture risk evaluation.

A handheld ultrasound transducer connects to a computer through USB. Gel couples it to the skin, and the operator holds it perpendicular to the cortical bone at the standardized upper tibial site. Five measurements are taken at each location.

Listed Item

Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41. Compartment for gel bottle included.

Interpretation Scope

The Density Index thresholds are validated for Caucasian and Hispanic women aged 50 to 90. A physician or trained health professional under physician supervision operates the system. The kit includes a measurement stick, with ultrasound gel optional.

1manufacturer

4catalogue numbers in this listing

3510(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 Bindex BI-2 Kit
Listed by	Bone Index Finland Ltd., Finland
FDA product code	MUA
Device type	Bone Sonometer
Device class	Class 2
Regulation	21 CFR 892.1180
Establishment	Manufacturer, Exporter
510(k)	K211350
Record published	2017-05-31
Record revised	2022-12-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 15 to 40 °C; Storage environment temperature 15 to 40 °C; Handling environment atmospheric pressure 700 to 1060 millibar; Handling environment humidity 5 to 90 % RH; Special storage condition: Fragile; Special storage condition: Keep dry

Catalogue Numbers

Catalogue numbers for Bindex BI-2 Kit
Catalogue number	Size	Status
v1 (w/ Gel)		In distribution
v4 (w/o Gel)		In distribution
v3 (w/o Gel)		In distribution
v2 (w/o Gel)		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Echolight S.p.a.	Echolight SPA	9
Bindex	Bone Index Finland Ltd.	2
BeamMed	BeamMed Ltd.	2
Achilles Expii	GE Medical Systems (China) Co., Ltd.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K211350	2022-04-29
K161971	2017-01-09
K152020	2016-05-13

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.