510(k) · Cleared
ClearedAIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
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 May 29, 2018 as substantially equivalent to K173021 (Supersonic Imagine, 2018) and 2 other predicates after an 85-day review. Its family tree reaches back 23 generations to 1995. 7 of the 354 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- May 29, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K935595 (1995). 337 ancestors in all, the oldest K844472 (1985). 16 later devices descend from it, 2 citing it directly. 7 of the 354 devices in this family, counting this one, have a Class I recall.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK152195 Logiq S8GE Healthcare · 2015
- 2 generations backK170445 Logiq S8GE Healthcare · 2017 · Recalled
- 1 generation backK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- This deviceK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
- Descendant · cites it directly · 9 of its ownK191467 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019
- Descendant · 2 generations on · 7 of its ownK201972 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020
- Descendant · 3 generations on · 6 of its ownK212333 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · 2022 · Recalled
- Descendant · 4 generations on · 5 of its ownK223017 Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation · 2023
- Descendant · cites it directly · 5 of its ownK191007 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine · 2019
Show all 23 generations
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 21 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 20 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 19 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 18 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 17 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 14 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 13 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 12 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 11 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 10 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 9 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 8 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 7 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 6 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 5 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 4 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 3 generations backK152195 Logiq S8GE Healthcare · 2015
- 2 generations backK170445 Logiq S8GE Healthcare · 2017 · Recalled
- 1 generation backK173021 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine · 2018
- This deviceK180572 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30…Supersonic Imagine · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation · 2019 · cites it directly9descendants
- K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation · 2020 · 2 generations on7descendants
- K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · 2022 · 3 generations on6descendants
- K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation · 2023 · 4 generations on5descendants
- K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine · 2019 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −22 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −21 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −20 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −19 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −18 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −17 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −14 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −13 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −12 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −11 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −10 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −9 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −8 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −7 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −6 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −5 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −4 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −3 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
| −2 | K170445 | Logiq S8 | GE Healthcare | 2017 | 1 |
| −1 | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Supersonic Imagine | 2018 | — |
| 0 (this device) | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach… | Supersonic Imagine | 2018 | — |
| +1 | K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | 2019 | — |
| +2 | K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020 | — |
| +3 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | 2022 | 1 |
| +4 | K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Canon Medical Systems Corporation | 2023 | — |
| +1 | K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Supersonic Imagine | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 7 | 1 |
| 1997 | 12 | 0 |
| 1998 | 19 | 3 |
| 1999 | 21 | 0 |
| 2000 | 17 | 1 |
| 2001 | 18 | 0 |
| 2002 | 26 | 0 |
| 2003 | 25 | 0 |
| 2004 | 19 | 1 |
| 2005 | 21 | 0 |
| 2006 | 15 | 0 |
| 2007 | 10 | 1 |
| 2008 | 13 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 12 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 3 | 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.
7 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? (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 |
|---|---|---|---|
| * | K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSummary page 14…-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K173021), cleared on 01/09/2018 FibroScan (K160524), cleared on 03/18/2016 Epiq 7 (K163120) cleared on 01/10/2017… | 2018 |
| * | K160524 | FibroScan 530 CompactSummary page 14…892.1570 90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K173021), cleared on 01/09/2018 FibroScan (K160524), cleared on 03/18/2016 Epiq 7 (K163120) cleared on 01/10/2017… | 2016 |
| * | K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Summary page 14…3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K173021), cleared on 01/09/2018 FibroScan (K160524), cleared on 03/18/2016 Epiq 7 (K163120) cleared on 01/10/2017… | 2017 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · 6 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 92 of the 337 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K191467 (Canon Medical Systems Corporation, 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K173021.
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. 2018, 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® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial…
Read the full statement (182 words)
The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general
purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following
applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal,
Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-
rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are
intended for:
- Measurements of abdominal anatomical structures,
- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
- Measurements of brightness ratio between liver and kidney,
- Visualization of abdominal vascularization, microvascularization and perfusion,
- Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,
microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical
management of adult and pediatric patients with liver disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180572
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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