510(k) · Cleared
ClearedUltraScan 650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberlogic, Inc. · MUA Bone Sonometer
Cleared on Apr 5, 2017 as substantially equivalent to K103633 (Ge Medical Systems China Co., Ltd., 2011) after a 266-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Apr 5, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- MUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P970040 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP970040 Achilles Express UltrasonometerGe Lunar Corp. · 1998 · Recalled
- 1 generation backK103633 AchillesGe Medical Systems China Co., Ltd. · 2011
- This deviceK161919 UltraScan 650Cyberlogic, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK180516 EchoSEcholight S.P.A · 2018
- Descendant · 2 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 3 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P970040 | Achilles Express Ultrasonometer | Ge Lunar Corp. | 1998 | 2 |
| −1 | K103633 | Achilles | Ge Medical Systems China Co., Ltd. | 2011 | — |
| 0 (this device) | K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017 | — |
| +1 | K180516 | EchoS | Echolight S.P.A | 2018 | — |
| +2 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +3 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103633 | AchillesSummary page 4…Bone sonometer Classification Name / Bone sonometer Product Classification MUA, 21CFR 892.1180, Class II Predicate Device: K103633 – GE Healthcare Achilles ultrasonometer Reference Devices: K110646 – BeamMed – Omnisense 7000S… | 2011 |
| † | K110646 | Beammed Sunlight Miniomni Bone Sonometer | 2011 |
| † | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180516 | EchoS | 2018 | 2 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K180516 (Echolight S.P.A, 2018) has gone furthest, with 2 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. 2017, 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?
UltraScan 650 can be used to determine BMDUS Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.
The BMDUS Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2.
BMDUS Index is expressed in grams/cm2 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 postmenopausal women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161919: UltraScan 650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161919
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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