510(k) · Cleared
ClearedEchoS
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 Oct 19, 2018 as substantially equivalent to K161919 (Cyberlogic, Inc., 2017) and 1 other predicate after a 234-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 19, 2018
- Review
- 234 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P970040 (1998). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP970040 Achilles Express UltrasonometerGe Lunar Corp. · 1998 · Recalled
- 2 generations backK103633 AchillesGe Medical Systems China Co., Ltd. · 2011
- 1 generation backK161919 UltraScan 650Cyberlogic, Inc. · 2017
- This deviceK180516 EchoSEcholight S.P.A · 2018
- Descendant · cites it directly · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 2 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P970040 | Achilles Express Ultrasonometer | Ge Lunar Corp. | 1998 | 2 |
| −2 | K103633 | Achilles | Ge Medical Systems China Co., Ltd. | 2011 | — |
| −1 | K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017 | — |
| 0 (this device) | K180516 | EchoS | Echolight S.P.A | 2018 | — |
| +1 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 K202514 EchoS Familyscore 5.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K161919 | UltraScan 650Summary page 4…quivalent to the following predicate devices: Applicant Device name 510(k) Number CyberLogic, Inc. Ultrascan 650 K161919 - Primary Predicate Device Beam-Med Ltd. Sunlight MiniOmni K110646 - Secondary Predicate Device 4. Dev… | 2017 |
| * | K110646 | Beammed Sunlight Miniomni Bone SonometerSummary page 4…510(k) Number CyberLogic, Inc. Ultrascan 650 K161919 - Primary Predicate Device Beam-Med Ltd. Sunlight MiniOmni K110646 - Secondary Predicate Device 4. Device Description The subject device, EchoS, consists of two main parts: the equipment EchoS… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202514 | EchoS Family | 2021 | 1 |
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 20 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K202514 (Echolight S.P.A, 2021) has gone furthest, with 1 descendant 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. 2018, 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?
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…
Read the full statement (159 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180516: EchoS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180516
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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