510(k) · Cleared
ClearedSonoline G20 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 Oct 27, 2004 as substantially equivalent to K040502 (Siemens Medical Solutions USA, Inc., 2004) and 2 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1994. 2 of the 937 devices in its family, counting itself, have a Class I recall. 928 later devices descend from it.
- Decided
- Oct 27, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933202 (1994). 8 ancestors in all. 928 later devices descend from it, 2 citing it directly. 2 of the 937 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 3 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- 2 generations backK991611 GE Logiq 500General Electric Co. · 1999
- 1 generation backK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- This deviceK042833 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 3 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- Descendant · 4 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 5 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
Showing 5 of 928 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 928 · See all- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly926descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 3 generations on801descendants
- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on800descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 5 generations on588descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −3 | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| −2 | K991611 | GE Logiq 500 | General Electric Co. | 1999 | — |
| −1 | K040502 | Sonoline Ebisu Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| 0 (this device) | K042833 | Sonoline G20 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +2 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +3 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| +4 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +5 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040502 | Sonoline Ebisu Diagnostic Ultrasound SystemsSummary page 2…is substantially equivalent to the SONOLINE Adara, cleared via K946179, the SONOLINE G50/G60 S, cleared via K020353, and the SONOLINE G20, clearedof via K040502. All systems transmit ultrasonic energy into patients, then perform post processing received echoes to gener… | 2004 |
| * | K020353 | Omnia X/XS Ultrasound SystemSummary page 2…cal Comparison to Predicate Device: The G20 is substantially equivalent to the SONOLINE Adara, cleared via K946179, the SONOLINE G50/G60 S, cleared via K020353, and the SONOLINE G20, clearedof via K040502. All systems transmit ultrasonic energy into patients, then perform… | 2002 |
| * | K946179 | Siemens Sonoline 4XXSummary page 2…for clinical diagnosis purposes. 6. Technological Comparison to Predicate Device: The G20 is substantially equivalent to the SONOLINE Adara, cleared via K946179, the SONOLINE G50/G60 S, cleared via K020353, and the SONOLINE G20, clearedof via K040502. All systems… | 1995 |
What descends from it? (928)
See all 9282 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 8 ancestors has a recall.
- Of its descendants, K052894 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 926 descendants of its own.
- 2 other devices also cite its predicate K040502.
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?
The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
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/K042833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042833: Sonoline G20 Diagnostic Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042833
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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