510(k) · Cleared
ClearedEchoS Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echolight S.P.A · MUA Bone Sonometer
Cleared on Feb 25, 2021 as substantially equivalent to K180516 (Echolight S.P.A, 2018) and 2 other predicates after a 178-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it.
- Decided
- Feb 25, 2021
- Review
- 178 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894632 (1989). 29 ancestors in all, the oldest K810116 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 5 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 4 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 3 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 2 generations backK051334 Terason Ultrasound System with Continuous Wave SopplerTeratech Corp. · 2005
- 1 generation backK082147 Bodymetrix BX2000Intelametrix, Inc. · 2009
- This deviceK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · cites it directly · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Most influential descendants
Showing 1 of 1 · See all- K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −5 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −4 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −3 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −2 | K051334 | Terason Ultrasound System with Continuous Wave Soppler | Teratech Corp. | 2005 | — |
| −1 | K082147 | Bodymetrix BX2000 | Intelametrix, Inc. | 2009 | — |
| 0 (this device) | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +1 | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUA device
- #1 K211350 Bindex BI-2score 4.2 · 4 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180516 | EchoSSummary page 5…rketed Predicate Device (s) 510(k) Pro Code Trade Name Applicant Number K180516 21 CFR 892.1180 EchoS Echolight S.p.a.… | 2018 |
| * | K082317 | GE Lunar Frax 10-Year Fracture Risk Software OptionSummary page 5…180516 21 CFR 892.1180 EchoS Echolight S.p.a. FRAX® 10-Year Fracture Risk K082317 21 CFR 892.1170 Software Option for GE Lunar General Electric Co.… | 2008 |
| * | K082147 | Bodymetrix BX2000Summary page 5…K082317 21 CFR 892.1170 Software Option for GE Lunar General Electric Co. Bone Densitometers K082147 21 CFR 870.2770 BodyMetrix BX2000TM IntelaMetrix, Incorporated IV. Device Description The Echo… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K212851 (Echolight S.P.A, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUA devicesMUA Bone Sonometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MUA
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MUA
Too few MUA 510(k)s in any year since 2007 to give a median.
Recalls per year · MUA
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUA
1in 2011
MAUDE reports naming product code MUA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (381 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202514: EchoS Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202514
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026