# K180516: EchoS

- Pathway: 510(k) (Traditional)
- Applicant: Echolight S.P.A
- Decided: Oct 19, 2018 after 234 days
- Product code: MUA (Bone Sonometer)
- Device class: 2
- Regulation: 21 CFR 892.1180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P970040 (1998). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161919: UltraScan 650, Cyberlogic, Inc. (2017) Summary page 4.
- K110646: Beammed Sunlight Miniomni Bone Sonometer, Beam-Med, Ltd. (2011) Summary page 4.

## Most influential descendants
- K202514: EchoS Family (2021), 1 descendant of its own
- K212851: EchoSK and EchoSGyn modules for EchoS Family devices (2022), 0 descendants of its own

## Indications for use
EchosS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDys, T-score, and Z-score) and to assess fracture risk through the integrated FRAX® software. The BMDyg Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD as provided by DXA at the same anatomical location (BMDpxa), with a standard error of the estimate of 0.044 grams/cm? for lumbar spine and 0.038 grams/cm? for femoral neck measurements. BMDys Index is expressed in grams/cm? and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDyg Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.

Source page: https://510kreport.com/device/K180516
Methodology: https://510kreport.com/methodology