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 28, 2012 as substantially equivalent to K091970 (Supersonic Imagine, 2009) and 1 other predicate after a 389-day review. Its family tree reaches back 13 generations to 1995. 2 of the 598 devices in its family, counting itself, have a Class I recall. 525 later devices descend from it.
- Decided
- Aug 28, 2012
- Review
- 389 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K935595 (1995). 72 ancestors in all, the oldest K891689 (1989). 525 later devices descend from it, 9 citing it directly. 2 of the 598 devices in this family, counting this one, have a Class I recall.
- 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 deviceK112255 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 · 212 of its ownK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · cites it directly · 177 of its ownK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens 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 deviceK112255 AixplorerSupersonic Imagine · 2012
Showing 5 of 525 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 525 · See all- K132274AixplorerSupersonic Imagine · 2013 · cites it directly312descendants
- K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · 2 generations on263descendants
- K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · cites it directly212descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 2 generations on211descendants
- K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013 · cites it directly177descendants
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) | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| +1 | K132274 | Aixplorer | Supersonic Imagine | 2013 | — |
| +2 | K142160 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2014 | 1 |
| +1 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| +2 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +1 | K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | 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 | 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 |
|---|---|---|---|
| * | K091970 | Aixplorer Ultrasound SystemSummary page 1…90-IYO Diagnostic Ultrasound Transducer 892.1570 I90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K091970), cleared August 12, 2009 AIXPLORER® Ultrasound Imaging System (K102041), cleared October 18, 2010 SUPERSONIC IMAGINE… | 2009 |
| * | K102041 | AixplorerSummary page 1…I90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K091970), cleared August 12, 2009 AIXPLORER® Ultrasound Imaging System (K102041), cleared October 18, 2010 SUPERSONIC IMAGINE page 2 of… | 2010 |
What descends from it? (525)
See all 5259 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132274 | Aixplorer | 2013 | 312 |
| K130499 | IU22 Diagnostic Ultrasound System | 2013 | 212 |
| K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | 2013 | 177 |
| K131164 | Acuson | 2013 | 124 |
| K130881 | Acuson S2000 and S3000 | 2013 | 116 |
| K132171 | Aixplorer | 2013 | 64 |
| K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50… | 2017 | 58 |
| K123806 | Fibroscan | 2013 | 55 |
| K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | 2014 | 39 |
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 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 K091970.
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 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/K112255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112255: Aixplorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112255
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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