FDA product code MUA: Bone Sonometer
MUA is the FDA product code for bone sonometer. It is a Class II device, regulated under 21 CFR 892.1180 and reviewed by the Radiology panel. FDA has cleared 9 510(k) submissions under MUA, 1 in the last five years, from 5 different applicants. The average 510(k) review took 224 days (median 222). 8 PMA applications cite this product code. FDA has posted 2 recalls for MUA devices.
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
Classification
| Field | Value |
|---|---|
| Device name | Bone Sonometer |
| Device class | Class II |
| Regulation | 21 CFR 892.1180 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for MUA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 220 |
| 2018 | 1 | 234 |
| 2021 | 1 | 178 |
| 2022 | 1 | 361 |
Compare with all 510(k) review times · Search every MUA clearance
Top MUA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bone Index Finland , Ltd. | 3 | 2022-04-29 |
| Echolight S.P.A | 2 | 2021-02-25 |
| Ge Medical Systems China Co., Ltd. | 2 | 2013-02-25 |
| Cyberlogic, Inc. | 1 | 2017-04-05 |
| Beam-Med, Ltd. | 1 | 2011-10-12 |
Most recent MUA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211350 | Bone Index Finland , Ltd. | Bindex BI-2 | 2022-04-29 | 361 |
| K202514 | Echolight S.P.A | EchoS Family | 2021-02-25 | 178 |
| K180516 | Echolight S.P.A | EchoS | 2018-10-19 | 234 |
| K161919 | Cyberlogic, Inc. | UltraScan 650 | 2017-04-05 | 266 |
| K161971 | Bone Index Finland , Ltd. | Bindex BI-2 | 2017-01-09 | 175 |
Recalls for MUA devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-03.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code MUA?
MUA is the FDA product code for bone sonometer. It is a Class II device, regulated under 21 CFR 892.1180 and reviewed by the Radiology panel.
What device class is MUA?
Class II, regulation 21 CFR 892.1180. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUA?
Across 9 cleared submissions the average was 224 days from receipt to decision (median 222).
Which companies have the most MUA clearances?
Bone Index Finland , Ltd. (3); Echolight S.P.A (2); Ge Medical Systems China Co., Ltd. (2); Cyberlogic, Inc. (1); Beam-Med, Ltd. (1).
Have MUA devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2019-09-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MUA
- Run a recall and safety report across every MUA manufacturer
- Watch product code MUA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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