510(k) · Cleared
ClearedSonoline Ebisu Diagnostic Ultrasound Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 9, 2004 as substantially equivalent to K020353 (Siemens Medical Systems, Inc., 2002) and 2 other predicates after an 11-day review. Its family tree reaches back 3 generations to 1994. 2 of the 938 devices in its family, counting itself, have a Class I recall. 930 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933202 (1994). 7 ancestors in all. 930 later devices descend from it, 3 citing it directly. 2 of the 938 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 2 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- 1 generation backK991611 GE Logiq 500General Electric Co. · 1999
- This deviceK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 928 of its ownK042833 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 927 of its ownK043016 Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 4 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
Showing 5 of 930 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 930 · See all- K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly928descendants
- K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly927descendants
- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on926descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 4 generations on801descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −2 | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| −1 | K991611 | GE Logiq 500 | General Electric Co. | 1999 | — |
| 0 (this device) | K040502 | Sonoline Ebisu Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K042833 | Sonoline G20 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K043016 | Sonoline Orchid Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +4 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 13 | 0 |
| 2010 | 15 | 0 |
| 2011 | 26 | 0 |
| 2012 | 30 | 0 |
| 2013 | 41 | 0 |
| 2014 | 45 | 0 |
| 2015 | 53 | 0 |
| 2016 | 59 | 0 |
| 2017 | 75 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 73 | 0 |
| 2021 | 53 | 0 |
| 2022 | 57 | 0 |
| 2023 | 57 | 0 |
| 2024 | 65 | 0 |
| 2025 | 79 | 2 |
| 2026 | 54 | 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.
2 devices in this family have a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K020353 | Omnia X/XS Ultrasound SystemSummary page 1…92.1560 Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K020353, 02/13/2002, cleared as Omnia X/XS, marketed as SONOLINE G50 & G60 S Diagnostic Ultrasound Systems K9461 79, 10… | 2002 |
| * | K946179 | Siemens Sonoline 4XXSummary page 1…90-ITX 3. Predicate Device: K020353, 02/13/2002, cleared as Omnia X/XS, marketed as SONOLINE G50 & G60 S Diagnostic Ultrasound Systems K9461 79, 10/03/1 995, cleared as Prima, and marketed as SONOLINE Adara Diagnostic Ultrasound System 4. Device Description… | 1995 |
| * | K991611 | GE Logiq 500Summary page 2…alent to the SONOLINE Adara, cleared via K946179, the SONOLINE G50/G60 S. cleared via K020353, and some features of the GE LOGIQ 500, cleared via K991611. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on… | 1999 |
What descends from it? (930)
See all 9303 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K042833 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 928 descendants of its own.
- 8 other devices also cite its predicate K020353.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
Diagnostic Imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040502: Sonoline Ebisu Diagnostic Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040502
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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