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 16, 2016 as substantially equivalent to K142100 (Supersonic Imagine, 2014) and 3 other predicates after a 119-day review. Its family tree reaches back 17 generations to 1995. 1 of the 239 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Nov 16, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K935595 (1995). 218 ancestors in all, the oldest K863700 (1987). 20 later devices descend from it, 1 citing it directly. 1 of the 239 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 2 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 1 generation backK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- This deviceK161999 AixplorerSupersonic Imagine · 2016
- Descendant · cites it directly · 19 of its ownK171105 AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017
- Descendant · 2 generations on · 18 of its ownK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- Descendant · 3 generations on · 16 of its ownK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
- Descendant · 4 generations on · 9 of its ownK191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019
- Descendant · 5 generations on · 7 of its ownK201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 13 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 8 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 7 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 5 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 4 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 3 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 2 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 1 generation backK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
- This deviceK161999 AixplorerSupersonic Imagine · 2016
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
Most influential descendants
Showing 5 of 20 · See all- K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine · 2017 · cites it directly19descendants
- K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018 · 2 generations on18descendants
- K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine · 2018 · 3 generations on16descendants
- K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019 · 4 generations on9descendants
- K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −13 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −11 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −7 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −5 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −4 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −3 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −2 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −1 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
| 0 (this device) | K161999 | Aixplorer | Supersonic Imagine | 2016 | — |
| +1 | K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Supersonic Imagine | 2017 | — |
| +2 | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018 | — |
| +3 | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach… | Supersonic Imagine | 2018 | — |
| +4 | K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | 2019 | — |
| +5 | K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 10 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 10 | 0 |
| 1999 | 16 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 16 | 0 |
| 2004 | 17 | 0 |
| 2005 | 16 | 0 |
| 2006 | 12 | 0 |
| 2007 | 5 | 1 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K142100 | AixplorerSummary page 4…sel Other (Specify) P P P P, 1, 3, 4 P, 5, 6, 8, 9 N = new indication; P = previously cleared by FDA (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 9: Panoramic Imaging 2: Combined modes in… | 2014 |
| * | K132274 | AixplorerSummary page 18…90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K142100), cleared on 11/20/2014 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Esaote S.p.A Ultrasound Imaging System (K133905), cleared on 04/15/2014 Toshiba System, Diagnostic Ultras… | 2013 |
| * | K133905 | 6200 / 6250 Ultrasound SystemSummary page 18…Ultrasound Imaging System (K142100), cleared on 11/20/2014 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Esaote S.p.A Ultrasound Imaging System (K133905), cleared on 04/15/2014 Toshiba System, Diagnostic Ultrasound (K133761), cleared on 22/04/2014 4) Description of Device The S… | 2014 |
| * | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0Summary page 18…Ultrasound Imaging System (K132274), cleared on 09/24/2013 Esaote S.p.A Ultrasound Imaging System (K133905), cleared on 04/15/2014 Toshiba System, Diagnostic Ultrasound (K133761), cleared on 22/04/2014 4) Description of Device The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging… | 2014 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | 2017 | 19 |
Has anything in its family been recalled? (1 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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 49 of the 218 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171105 (Supersonic Imagine, 2017) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K142100.
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. 2016, 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, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal,
Neonatal/Adult Cephalic, and Non-invasive Cardiac.
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, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161999: Aixplorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161999
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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