510(k) · Cleared
ClearedAixplorer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Supersonic Imagine · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Oct 13, 2010 as substantially equivalent to K091970 (Supersonic Imagine, 2009) and 2 other predicates after an 86-day review. Its family tree reaches back 12 generations to 1995. 2 of the 599 devices in its family, counting itself, have a Class I recall. 527 later devices descend from it.
- Decided
- Oct 13, 2010
- Review
- 86 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K935595 (1995). 71 ancestors in all, the oldest K891689 (1989). 527 later devices descend from it, 2 citing it directly. 2 of the 599 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- This deviceK102041 AixplorerSupersonic Imagine · 2010
- Descendant · cites it directly · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 212 of its ownK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- This deviceK102041 AixplorerSupersonic Imagine · 2010
Showing 5 of 527 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 527 · See all- K112255AixplorerSupersonic Imagine · 2012 · cites it directly525descendants
- K121329AixplorerSupersonic Imagine · 2012 · cites it directly405descendants
- K132274AixplorerSupersonic Imagine · 2013 · 2 generations on312descendants
- K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · 3 generations on263descendants
- K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 2 generations on212descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | 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 |
| −2 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| 0 (this device) | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| +1 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| +1 | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| +2 | K132274 | Aixplorer | Supersonic Imagine | 2013 | — |
| +3 | K142160 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2014 | 1 |
| +2 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
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 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K091970 | Aixplorer Ultrasound SystemSummary page 1…IYO Diagnostic Ultrasound Transducer 1 892.1570 I90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K091970), cleared on 08/12/2009 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/1 3/2007 Philips iU22 Ultr… | 2009 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K091970), cleared on 08/12/2009 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/1 3/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010 SUPERSONIC IMAGINE… | 2007 |
| * | K093563 | IU22 Ultrasound System and TransducersSummary page 1…d Imaging System (K091970), cleared on 08/12/2009 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/1 3/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010 SUPERSONIC IMAGINE CONFIDENTIAL page 2 of… | 2010 |
What descends from it? (527)
See all 5272 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 15 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 18 of the 71 ancestors have a recall of any class.
- Of its descendants, K112255 (Supersonic Imagine, 2012) has gone furthest, with 525 descendants of its own.
- 1 other device also cites its predicate K091970.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal and Trans-vaginal.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal and Trans-vaginal).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102041: Aixplorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102041
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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