510(k) · Cleared
Recalled · 2011Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 12, 2005 as substantially equivalent to K030949 (Sonosite,Inc., 2003) and 3 other predicates after a 16-day review. Its family tree reaches back 3 generations to 1995. 678 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 12, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945773 (1995). 6 ancestors in all. 678 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 2 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 1 generation backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- This deviceK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005
- Descendant · cites it directly · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- Descendant · 2 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · cites it directly · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 678 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 678 · See all- K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · cites it directly676descendants
- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 2 generations on584descendants
- K080223Zura Tee SystemImacor, LLC · 2008 · cites it directly583descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −2 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −1 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| 0 (this device) | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | — |
| +1 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| +2 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +1 | K080223 | Zura Tee System | Imacor, LLC | 2008 | 1 |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 25 | 0 |
| 2013 | 25 | 0 |
| 2014 | 39 | 0 |
| 2015 | 38 | 0 |
| 2016 | 48 | 0 |
| 2017 | 53 | 0 |
| 2018 | 52 | 0 |
| 2019 | 40 | 0 |
| 2020 | 57 | 0 |
| 2021 | 42 | 0 |
| 2022 | 47 | 0 |
| 2023 | 42 | 0 |
| 2024 | 48 | 0 |
| 2025 | 54 | 0 |
| 2026 | 35 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030949 | Titan High Resolution Ultrasound SystemSummary page 1…noSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite TITANT M Ultrasound System (K030949), Philips Ultrasound HDI® 5000 Ultrasound System (K011224), the GE LOGIQ 9 Diagnostic Ultrasound System… | 2003 |
| * | K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…Summary page 1…bstantially equivalent to a combination of the SonoSite TITANT M Ultrasound System (K030949), Philips Ultrasound HDI® 5000 Ultrasound System (K011224), the GE LOGIQ 9 Diagnostic Ultrasound System (K01 1188) and the Siemens OMNIA X/XS Diagnostic Ultrasound System (K… | 2001 |
| * | K011188 | GE Logiq 9, Model 2188900-XSummary page 1…TITANT M Ultrasound System (K030949), Philips Ultrasound HDI® 5000 Ultrasound System (K011224), the GE LOGIQ 9 Diagnostic Ultrasound System (K01 1188) and the Siemens OMNIA X/XS Diagnostic Ultrasound System (K020353). 510(K) Summary Of Safety And Effectiveness… | 2001 |
| * | K020353 | Omnia X/XS Ultrasound SystemSummary page 1…HDI® 5000 Ultrasound System (K011224), the GE LOGIQ 9 Diagnostic Ultrasound System (K01 1188) and the Siemens OMNIA X/XS Diagnostic Ultrasound System (K020353). 510(K) Summary Of Safety And Effectiveness Page 1 of 6… | 2002 |
| † | K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System… | 2003 |
What descends from it? (678)
See all 6785 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2011 | Not classified | Z-0057-2012 | Software design | This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment. |
| Nov 2, 2007 | Not classified | Z-2655-2010 | Process control | Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer. |
| Nov 2, 2007 | Not classified | Z-2654-2010 | Process control | Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer. |
| Feb 5, 2007 | Not classified | Z-0661-2007 | Other | Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K053069 (Sonosite,Inc., 2005) has gone furthest, with 676 descendants of its own.
- 3 other devices also cite its predicate K030949.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow…
Read the full statement (273 words)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043559 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043559
Report an extraction error
Are you the manufacturer?
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