510(k) · Cleared
ClearedShear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuxi Hisky Medical Technologies Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 1, 2025 as substantially equivalent to K200136 (Wuxi Hisky Medical Technologies Co., Ltd., 2020) after a 268-day review. Its family tree reaches back 23 generations to 1995.
- Decided
- Oct 1, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K935595 (1995). 192 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- 2 generations backK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- 1 generation backK200136 Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd. · 2020
- This deviceK250026 Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd. · 2025
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 backK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
- 9 generations backK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
- 8 generations backK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
- 7 generations backK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
- 6 generations backK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014
- 5 generations backK150949 FibroScanEchosens · 2015
- 4 generations backK160524 FibroScan 530 CompactEchosens · 2016
- 3 generations backK173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2017
- 2 generations backK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- 1 generation backK200136 Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd. · 2020
- This deviceK250026 Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd. · 2025
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 | K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio… | Toshiba America Medical Systems, In.C | 2011 | — |
| −9 | K121422 | Aplio 500/400/300 Diagnostic Ultrasound System | Toshiba Medical Systems Coporation, Japan | 2012 | — |
| −8 | K123992 | Aplio 500/400/300 V3.0 | Toshibamedical Systems Corporation | 2013 | — |
| −7 | K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | 2014 | — |
| −6 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | — |
| −5 | K150949 | FibroScan | Echosens | 2015 | — |
| −4 | K160524 | FibroScan 530 Compact | Echosens | 2016 | — |
| −3 | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017 | — |
| −2 | K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2018 | — |
| −1 | K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | 2020 | — |
| 0 (this device) | K250026 | Shear Wave Quantificational Ultrasound Diagnostic System… | Wuxi Hisky Medical Technologies Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 5 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 14 | 0 |
| 2000 | 8 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 16 | 0 |
| 2005 | 13 | 0 |
| 2006 | 12 | 0 |
| 2007 | 4 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K200136 | Shear Wave Quantificational Ultrasound Diagnostic SystemSummary page 6…ltrasound Diagnostic System Common Name Diagnostic Ultrasound System and Accessories Model Name FT9000, FT100, Mini800 510(k) number K200136 Classification name 1) Ultrasonic Pulsed Echo Imaging System 2) Diagnostic Ultrasound Transducer… | 2020 |
| † | K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 11 companies; a new generation was cleared every 11 months on median.
- 38 of the 192 ancestors have a recall of any class.
- 1 other device also cites its predicate K200136.
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. 2025, 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?
Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue…
Read the full statement (178 words)
Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.
Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue stiffness in spleen.
Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.
Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis in the human body (including abdominal applications) in B, M, CFM, PWD, B/B, 4B, B+M, B+CFM, B+PWD, and B+CFM+PWD modes.
The system must be operated by qualified and appropriately trained medical professionals in a professional healthcare facility environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250026: Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250026
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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