510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MUAClass II

Bone Sonometer

21 CFR 892.1180 / Radiology
FDA source (opens on fda.gov)

MUA is the FDA product code for Bone Sonometer, a class II device type, regulated under 21 CFR 892.1180. FDA's definition for this code reads: "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...". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MUA
Device name
Bone Sonometer
FDA 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
Regulation
21 CFR 892.1180
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
2

Clearances, product code MUA

By decision year
9 clearances under product code MUA with a decision year between 2011 and 2022, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MUA by decision year
YearClearances
20112
20131
20161
20172
20181
20211
20221

Applicants with the most clearances

Product code MUA
Applicants holding the most 510(k) clearances under product code MUA
ApplicantClearances
Bone Index Finland Ltd.3
Echolight S.p.A.2
GE Medical Systems China Co., Ltd.2
Beam-Med, Ltd.1
Cyberlogic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code