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 Nov 20, 2014 as substantially equivalent to K132171 (Supersonic Imagine, 2013) and 3 other predicates after a 111-day review. Its family tree reaches back 15 generations to 1995. 63 later devices descend from it.
- Decided
- Nov 20, 2014
- Review
- 111 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K935595 (1995). 76 ancestors in all, the oldest K891689 (1989). 63 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK102041 AixplorerSupersonic Imagine · 2010
- 2 generations backK121329 AixplorerSupersonic Imagine · 2012
- 1 generation backK132171 AixplorerSupersonic Imagine · 2013
- This deviceK142100 AixplorerSupersonic Imagine · 2014
- Descendant · cites it directly · 58 of its ownK163120 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
- Descendant · 3 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 24 of its ownK200304 EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 21 of its ownK202216 EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 2020 · Recalled
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 3 generations backK102041 AixplorerSupersonic Imagine · 2010
- 2 generations backK121329 AixplorerSupersonic Imagine · 2012
- 1 generation backK132171 AixplorerSupersonic Imagine · 2013
- This deviceK142100 AixplorerSupersonic Imagine · 2014
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc. · 2017 · cites it directly58descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 2 generations on28descendants
- K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 3 generations on27descendants
- K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · 4 generations on24descendants
- K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 2020 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −3 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −2 | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| −1 | K132171 | Aixplorer | Supersonic Imagine | 2013 | — |
| 0 (this device) | K142100 | Aixplorer | Supersonic Imagine | 2014 | — |
| +1 | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2017 | 28 |
| +2 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
| +3 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic… | Philips Ultrasound, Inc. | 2018 | 24 |
| +4 | K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020 | 3 |
| +5 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | 2020 | 8 |
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 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 9 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K132171 | AixplorerSummary page 13…90-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K132171), cleared on 09/24/2013 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Siemens Acuson S2000TM Diagnostic U… | 2013 |
| * | K132274 | AixplorerSummary page 13…90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K132171), cleared on 09/24/2013 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultraso… | 2013 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 13…maging System (K132171), cleared on 09/24/2013 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 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 13…ound Imaging System (K132274), cleared on 09/24/2013 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 1 of 5… | 2010 |
| † | K121329 | Aixplorer | 2012 |
What descends from it? (63)
See all 632 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 19 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 18 of the 76 ancestors have a recall of any class.
- Of its descendants, K163120 (Philips Ultrasound, Inc., 2017) has gone furthest, with 58 descendants of its own.
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. 2014, 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, Musculoskelatal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative,
OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic.
The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal,
Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Neonatal/
Adult Cephalic, Fetal/Obstetrics).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142100: Aixplorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142100
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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