510(k) · Cleared
ClearedHepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 3, 2025 as substantially equivalent to K200643 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2020) after a 190-day review. Its family tree reaches back 28 generations to 1995.
- Decided
- Dec 3, 2025
- Review
- 190 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 28 generations to K935595 (1995). 250 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet.
- Root · 28 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations between
- 3 generations backK161525 TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- 2 generations backK180912 TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- 1 generation backK200643 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020
- This deviceK251601 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2025
Show all 28 generations
- Root · 28 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 27 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 26 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 25 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 24 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 23 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 22 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 21 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 20 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 19 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 18 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 17 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 16 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 15 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 14 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 13 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 12 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 11 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 10 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
- 9 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 8 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 7 generations backK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- 6 generations backK143472 TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 5 generations backK152543 M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 4 generations backK160381 TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- 3 generations backK161525 TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- 2 generations backK180912 TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- 1 generation backK200643 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020
- This deviceK251601 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −27 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −26 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −25 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −24 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −23 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −22 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −21 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −20 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −19 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −18 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −17 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −16 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −15 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −14 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −13 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −12 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −11 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −10 | 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 | — |
| −9 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −8 | K131690 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −7 | K141010 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| −6 | K143472 | TE7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −5 | K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −4 | K160381 | TE7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| −3 | K161525 | TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| −2 | K180912 | TE7/TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| −1 | K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | — |
| 0 (this device) | K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 10 | 0 |
| 2001 | 15 | 0 |
| 2002 | 12 | 0 |
| 2003 | 15 | 0 |
| 2004 | 17 | 0 |
| 2005 | 16 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 12 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 11 | 0 |
| 2012 | 13 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 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 |
|---|---|---|---|
| * | K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Summary page 5…Hepatus 7 series Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate device and reference devices listed below. Hepatus 7 (K200643)is the primary predicate device. 1 Device Man… | 2020 |
| † | K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic… | 2024 |
| † | K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10… | 2024 |
| † | K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | 2021 |
| † | 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 4 companies; a new generation was cleared every 8 months on median.
- 62 of the 250 ancestors have a recall of any class.
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?
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric, small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo- skeletal (superficial), thoracic/pleural, Cardiac Adult…
Read the full statement (290 words)
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric, small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo- skeletal (superficial), thoracic/pleural, Cardiac Adult, Cardiac Pediatric and Peripheral vessel exams.
It is intended to provide 50Hz shear wave speed measurements (ViTE: Visual Transient Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body.
It is also intended to measure spleen stiffness using ViTE at 100 Hz shear wave frequency.
The liver stiffness measurement by ViTE may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis.
The coefficient of attenuation measurement by LiSA may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.
ViTE and LiSA is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of patients with liver disease, as part of an overall assessment of liver.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PW Doppler, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging (Contrast agent for Liver), ViTE, LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B, iScape View, TDI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251601: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251601
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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