PMA · Approved
Recalled · Class II · 2019Achilles Express Ultrasonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Lunar Corp. · MUA Bone Sonometer
Approved on Jun 26, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 297-day review. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 26, 1998
- Review
- 297 days
- Class
- Class II
- Product code
- MUA
- Recalls
- 2
5 later devices descend from it, 1 citing it directly.
- This deviceP970040 Achilles Express UltrasonometerGe Lunar Corp. · 1998
- Descendant · cites it directly · 4 of its ownK103633 AchillesGe Medical Systems China Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK161919 UltraScan 650Cyberlogic, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK180516 EchoSEcholight S.P.A · 2018
- Descendant · 4 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 5 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Most influential descendants
Showing 5 of 5 · See all- K103633AchillesGe Medical Systems China Co., Ltd. · 2011 · cites it directly4descendants
- K161919UltraScan 650Cyberlogic, Inc. · 2017 · 2 generations on3descendants
- K180516EchoSEcholight S.P.A · 2018 · 3 generations on2descendants
- K202514EchoS FamilyEcholight S.P.A · 2021 · 4 generations on1descendant
- K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P970040 | Achilles Express Ultrasonometer | Ge Lunar Corp. | 1998 | — |
| +1 | K103633 | Achilles | Ge Medical Systems China Co., Ltd. | 2011 | — |
| +2 | K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017 | — |
| +3 | K180516 | EchoS | Echolight S.P.A | 2018 | — |
| +4 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +5 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103633 | Achilles | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2019 | Class II | Z-0112-2020 | Device Design | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection. |
| Sep 3, 2019 | Class II | Z-0113-2020 | Device Design | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103633 (Ge Medical Systems China Co., Ltd., 2011) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/P970040 · printed Nov 3, 2026
Cite this page
510(k) Report. “P970040: Achilles Express Ultrasonometer.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P970040
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026