510(k) · Cleared
ClearedAixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
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 Oct 25, 2019 as substantially equivalent to K180572 (Supersonic Imagine, 2018) and 2 other predicates after a 192-day review. Its family tree reaches back 26 generations to 1995. 7 of the 440 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Oct 25, 2019
- Review
- 192 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 26 generations to K935595 (1995). 434 ancestors in all, the oldest K844472 (1985). 5 later devices descend from it, 3 citing it directly. 7 of the 440 devices in this family, counting this one, have a Class I recall.
- Root · 26 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations between
- 3 generations backK152763 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 2 generations backK162267 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- 1 generation backK171233 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017
- This deviceK191007 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine · 2019
- Descendant · cites it directly · 2 of its ownK203645 Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC…Supersonic Imagine · 2021
- Descendant · 2 generations on · 1 of its ownK222191 Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC…Supersonic Imagine · 2022
- Descendant · cites it directly · 0 of its ownK261272 ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal…Esonic Technology (Wuhan) Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK242223 SuperSonic HepaVuSupersonic Imagine · 2024
- Descendant · cites it directly · 0 of its ownK202455 Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic…Supersonic Imagine · 2020
Show all 26 generations
- Root · 26 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 25 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 24 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 23 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 22 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 21 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 20 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 19 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 18 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 17 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 16 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 15 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 14 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 13 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 12 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 11 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 10 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 9 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 8 generations backK113647 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011
- 7 generations backK120699 DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 6 generations backK123503 DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 5 generations backK132779 DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 4 generations backK150204 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 3 generations backK152763 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 2 generations backK162267 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- 1 generation backK171233 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017
- This deviceK191007 Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine · 2019
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine · 2021 · cites it directly2descendants
- K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine · 2022 · 2 generations on1descendant
- K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd. · 2026 · cites it directly0descendants
- K242223SuperSonic HepaVuSupersonic Imagine · 2024 · 3 generations on0descendants
- K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −25 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −24 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −23 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −22 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −21 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −20 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −19 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −18 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −17 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −16 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −15 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −14 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −13 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −12 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −11 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −10 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −9 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −8 | K113647 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011 | — |
| −7 | K120699 | DC-T6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −6 | K123503 | DC-N3/DC-NS3 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −5 | K132779 | DC-N2/DC-N2S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −4 | K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −3 | K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −2 | K162267 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| −1 | K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017 | — |
| 0 (this device) | K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Supersonic Imagine | 2019 | — |
| +1 | K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20… | Supersonic Imagine | 2021 | — |
| +2 | K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20… | Supersonic Imagine | 2022 | — |
| +1 | K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/… | Esonic Technology (Wuhan) Co., Ltd. | 2026 | — |
| +3 | K242223 | SuperSonic HepaVu | Supersonic Imagine | 2024 | — |
| +1 | K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 &… | Supersonic Imagine | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 12 | 0 |
| 1996 | 9 | 1 |
| 1997 | 14 | 0 |
| 1998 | 20 | 3 |
| 1999 | 24 | 0 |
| 2000 | 20 | 1 |
| 2001 | 26 | 0 |
| 2002 | 26 | 0 |
| 2003 | 26 | 0 |
| 2004 | 21 | 1 |
| 2005 | 26 | 0 |
| 2006 | 19 | 0 |
| 2007 | 17 | 1 |
| 2008 | 18 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 0 |
| 2011 | 15 | 0 |
| 2012 | 17 | 0 |
| 2013 | 16 | 0 |
| 2014 | 13 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Summary page 4…Other (Specify) P P P P : 1, 3, 4 P : 5, 6, 8, 9, 10, 15 N = new indication; P = Previously cleared by FDA (K180572) 1: Combined modes include: B+ Color Flow 12: Combined modes include: B Mode + Color flow + ShearwaveTM Elas… | 2018 |
| * | K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Summary page 14…90-ITX 3) Substantially Equivalent/Predicate Devices AIXPLORER® MACH range Ultrasound Imaging System (K180572), cleared on 05/29/2018 Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 Resona 7 (K171233) cleared on 09/12/2017… | 2018 |
| * | K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemSummary page 14…/Predicate Devices AIXPLORER® MACH range Ultrasound Imaging System (K180572), cleared on 05/29/2018 Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 Resona 7 (K171233) cleared on 09/12/2017… | 2017 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC… | 2021 | 2 |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/… | 2026 | 0 |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc… | 2020 | 0 |
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 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 6 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · 7 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 24 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 111 of the 434 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K203645 (Supersonic Imagine, 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K180572.
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. 2019, 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 range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity 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…
Read the full statement (184 words)
The SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity 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 shearwave speed, beam attenuation, viscosity 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/K191007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K191007: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K191007
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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