510(k) · Cleared
ClearedAchilles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems China Co., Ltd. · MUA Bone Sonometer
Cleared on May 11, 2011 as substantially equivalent to P970040 (Ge Lunar Corp., 1998) after a 149-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- May 11, 2011
- Review
- 149 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P970040 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP970040 Achilles Express UltrasonometerGe Lunar Corp. · 1998 · Recalled
- This deviceK103633 AchillesGe Medical Systems China Co., Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK161919 UltraScan 650Cyberlogic, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK180516 EchoSEcholight S.P.A · 2018
- Descendant · 3 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 4 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Most influential descendants
Showing 4 of 4 · See all- K161919UltraScan 650Cyberlogic, Inc. · 2017 · cites it directly3descendants
- K180516EchoSEcholight S.P.A · 2018 · 2 generations on2descendants
- K202514EchoS FamilyEcholight S.P.A · 2021 · 3 generations on1descendant
- K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P970040 | Achilles Express Ultrasonometer | Ge Lunar Corp. | 1998 | 2 |
| 0 (this device) | K103633 | Achilles | Ge Medical Systems China Co., Ltd. | 2011 | — |
| +1 | K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017 | — |
| +2 | K180516 | EchoS | Echolight S.P.A | 2018 | — |
| +3 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +4 | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | P970040 | Achilles Express Ultrasonometer The summary prints P970040, a PMA number, which our reading took as K970040. Corrected to the number the summary prints. | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161919 | UltraScan 650 | 2017 | 3 |
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?
- Its one ancestor has a recall.
- Of its descendants, K161919 (Cyberlogic, Inc., 2017) has gone furthest, with 3 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. 2011, 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?
The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or…
Read the full statement (126 words)
The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.
Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.
The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103633: Achilles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103633
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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