510(k) · Cleared
ClearedAixplorer Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Supersonic Imagine · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 12, 2009 as substantially equivalent to K072786 (Siemens Medical Solutions USA, Inc., 2007) and 1 other predicate after a 42-day review. Its family tree reaches back 11 generations to 1995. 2 of the 592 devices in its family, counting itself, have a Class I recall. 528 later devices descend from it.
- Decided
- Aug 12, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K935595 (1995). 63 ancestors in all, the oldest K891689 (1989). 528 later devices descend from it, 2 citing it directly. 2 of the 592 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- Descendant · cites it directly · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
- Descendant · cites it directly · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
- Descendant · 2 generations on · 405 of its ownK121329 AixplorerSupersonic Imagine · 2012
- Descendant · 2 generations on · 312 of its ownK132274 AixplorerSupersonic Imagine · 2013
- Descendant · 3 generations on · 263 of its ownK142160 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · Recalled
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
Showing 5 of 528 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 528 · See all- K102041AixplorerSupersonic Imagine · 2010 · cites it directly527descendants
- K112255AixplorerSupersonic Imagine · 2012 · cites it directly525descendants
- K121329AixplorerSupersonic Imagine · 2012 · 2 generations on405descendants
- K132274AixplorerSupersonic Imagine · 2013 · 2 generations on312descendants
- K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · 3 generations on263descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −5 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | 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 | — |
| −2 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −1 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| 0 (this device) | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| +1 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| +1 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| +2 | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| +2 | K132274 | Aixplorer | Supersonic Imagine | 2013 | — |
| +3 | K142160 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 10 | 0 |
| 2014 | 14 | 0 |
| 2015 | 30 | 0 |
| 2016 | 36 | 0 |
| 2017 | 49 | 0 |
| 2018 | 41 | 0 |
| 2019 | 32 | 0 |
| 2020 | 47 | 0 |
| 2021 | 45 | 0 |
| 2022 | 44 | 0 |
| 2023 | 38 | 0 |
| 2024 | 45 | 0 |
| 2025 | 54 | 2 |
| 2026 | 40 | 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 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? (2)
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 |
|---|---|---|---|
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX 3) Substantially Equivalent/Predicate Devices Siemens Acuson S2000T Ultrasound System (K072786), 11/13/2007 Philips Ultrasound Boris Platform Diagnostic Ultrasound System (K030455), 3/13/2003 4) Description of Device The S… | 2007 |
| * | K030455 | Boris Platform Diagnostic Ultrasound SystemSummary page 1…Substantially Equivalent/Predicate Devices Siemens Acuson S2000T Ultrasound System (K072786), 11/13/2007 Philips Ultrasound Boris Platform Diagnostic Ultrasound System (K030455), 3/13/2003 4) Description of Device The SuperSonic imagine AIXPLORER® system is a cart based ultrasound imaging system used to… | 2003 |
What descends from it? (528)
See all 5282 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 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 16 of the 63 ancestors have a recall of any class.
- Of its descendants, K102041 (Supersonic Imagine, 2010) has gone furthest, with 527 descendants of its own.
- 15 other devices also cite its predicate K072786.
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. 2009, this device’s year, is highlighted.
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?
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskelelal and Peripheral Vascular.
The system also provides the abilily to measure anatomical structures (abdominal, small organs, rnusculoskeletal, superficial musculoskeletal and peripheral vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091970: Aixplorer Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091970
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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