510(k) · Cleared
ClearedAixplorer
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 24, 2012 as substantially equivalent to K102041 (Supersonic Imagine, 2010) and 2 other predicates after a 114-day review. Its family tree reaches back 13 generations to 1995. 405 later devices descend from it.
- Decided
- Aug 24, 2012
- Review
- 114 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K935595 (1995). 72 ancestors in all, the oldest K891689 (1989). 405 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 1 generation backK102041 AixplorerSupersonic Imagine · 2010
- This deviceK121329 AixplorerSupersonic Imagine · 2012
- Descendant · cites it directly · 312 of its ownK132274 AixplorerSupersonic Imagine · 2013
- Descendant · 2 generations on · 263 of its ownK142160 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · Recalled
- Descendant · cites it directly · 177 of its ownK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 124 of its ownK131164 AcusonSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 116 of its ownK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 4 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 1 generation backK102041 AixplorerSupersonic Imagine · 2010
- This deviceK121329 AixplorerSupersonic Imagine · 2012
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 405 · See all- K132274AixplorerSupersonic Imagine · 2013 · cites it directly312descendants
- K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · 2 generations on263descendants
- K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013 · cites it directly177descendants
- K131164AcusonSiemens Medical Solutions USA, Inc. · 2013 · cites it directly124descendants
- K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013 · cites it directly116descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | 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 |
| −3 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −1 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| 0 (this device) | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| +1 | K132274 | Aixplorer | Supersonic Imagine | 2013 | — |
| +2 | K142160 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2014 | 1 |
| +1 | K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K131164 | Acuson | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K130881 | Acuson S2000 and S3000 | Siemens Medical Solutions USA, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 16 | 0 |
| 2016 | 24 | 0 |
| 2017 | 31 | 0 |
| 2018 | 36 | 0 |
| 2019 | 28 | 0 |
| 2020 | 38 | 0 |
| 2021 | 36 | 0 |
| 2022 | 38 | 0 |
| 2023 | 30 | 0 |
| 2024 | 39 | 0 |
| 2025 | 43 | 0 |
| 2026 | 30 | 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? (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 |
|---|---|---|---|
| * | K102041 | AixplorerSummary page 1…90-IYO Diagnostic Ultrasound Transducer 892.1570 190-ITX 3) Substantially EquivalentiPredicate Devices AIXPLORERG Ultrasound Imaging System (K1 02041), cleared on 10/13/2010 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultraso… | 2010 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…3) Substantially EquivalentiPredicate Devices AIXPLORERG Ultrasound Imaging System (K1 02041), cleared on 10/13/2010 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010 SUPERSONIC IMAGINE… | 2007 |
| * | K093563 | IU22 Ultrasound System and TransducersSummary page 1…und Imaging System (K1 02041), cleared on 10/13/2010 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010 SUPERSONIC IMAGINE page 2 of 5… | 2010 |
What descends from it? (405)
See all 4055 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 18 of the 72 ancestors have a recall of any class.
- Of its descendants, K132274 (Supersonic Imagine, 2013) has gone furthest, with 312 descendants of its own.
- 1 other device also cites its predicate K102041.
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. 2012, 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 Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal Cephalic).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121329: Aixplorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121329
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