# K202514: EchoS Family

- Pathway: 510(k) (Traditional)
- Applicant: Echolight S.P.A
- Decided: Feb 25, 2021 after 178 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: 6 generations back to K894632 (1989). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180516: EchoS, Echolight S.P.A (2018) Summary page 5.
- K082317: GE Lunar Frax 10-Year Fracture Risk Software Option, General Electric Co. (2008) Summary page 5.
- K082147: Bodymetrix BX2000, Intelametrix, Inc. (2009) Summary page 5.

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

## Indications for use
1) EchoS Family is a non-invasive ultrasound (US) bone sonometer. EchoS Family works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDus, T-score, and Z-score). The BMDus 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 of the same anatomical location as provided by DXA (BMDDXA), with a standard error of the estimate of 0.044grams/cm^2 for lumbar spine and 0.038 grams/cm^2 for femoral neck measurements. BMDus Index is expressed in grams/cm^2 and as a T- and Z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women and men. 2) The EchoStudio software includes an optional tool called Fragility Score, which is intended to provide an assessment of 5-year fracture risk. The optional tool Fragility Score provides an estimate of 5-year probability of hip fracture and 5-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate takes into account the patient's age, sex, ethnicity, height, weight, and the vertebra/femur neck ultrasound spectra and is computed using a proprietary algorithm. The tool has been validated for men and women between 30 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool. The results can be used by a physician, in conjunction with other clinical risk factors, as an aid in the diagnosis of osteoporosis and medical conditions leading to increased bone fragility, and ultimately in the assessment of fracture risk. 3) EchoS Family, when used with the optional Body Composition module of EchoStudio software, is indicated to estimate total body fat percentage (%BF). EchoS Family, together with Body Composition software module, is intended to be used only on generally healthy adults and is not for diagnosis of disease or condition. Body Composition software is indicated for the calculation of the Body Mass Index (BMI) and the Basal Metabolic Rate (BMR). Body Composition software module generates a report which displays the calculated values of Body FAT, BMR, and Body Mass Index (BMI).

Source page: https://510kreport.com/device/K202514
Methodology: https://510kreport.com/methodology