510(k) · Cleared
ClearedModel EC9-4 Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Apr 19, 2006 as substantially equivalent to K050034 (Siemens Medical Solutions USA, Inc., 2005) after a 19-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Apr 19, 2006
- Review
- 19 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935595 (1995). 21 ancestors in all, the oldest K921148 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 4 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 3 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- This deviceK060879 Model EC9-4 TransducerSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK093706 Proxiscan Model 101Hybridyne Imaging Technologies, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −5 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −4 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −3 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −2 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K050034 | Sonoline Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| 0 (this device) | K060879 | Model EC9-4 Transducer | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K093706 | Proxiscan Model 101 | Hybridyne Imaging Technologies, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K050034 | Sonoline Antares Diagnostic Ultrasound SystemSummary page 1…icateDevices: The EC9-4 transducer has already been cleared on the following Siemens Medical Solutions' ultrasound platform: * ACUSON AntaresTm ultrasound platform (#K050034) Device Description: Presently cleared EC9-4 endocavity curved array ultrasound transducer is primarily indicated for transrect… | 2005 |
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 |
|---|---|---|---|
| K093706 | Proxiscan Model 101 | 2010 | 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 11 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K093706 (Hybridyne Imaging Technologies, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K050034.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The EC9-4 endocavity curved array ultrasound transducer is primarily indicated for transrectal and transvaginal, fetal and neonatal and small parts applications on the ACUSON Antares ultrasound imaging platform.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060879: Model EC9-4 Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060879
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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