510(k) · Cleared
ClearedNavi e/Navi s/Navi X Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Wisonic Medical Technology Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 9, 2018 as substantially equivalent to K143472 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2015) after a 78-day review. Its family tree reaches back 23 generations to 1995. 1 later device descends from it.
- Decided
- May 9, 2018
- Review
- 78 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K935595 (1995). 200 ancestors in all, the oldest K852159 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 2 generations backK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- 1 generation backK143472 TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- This deviceK180461 Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK182715 Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd. · 2018
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 backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 19 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 18 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 17 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 16 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 15 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 14 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 13 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 12 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 11 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 10 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 9 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 8 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 7 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 6 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 5 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
- 4 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 3 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 2 generations backK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- 1 generation backK143472 TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- This deviceK180461 Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd. · 2018 · cites it directly0descendants
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 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −19 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −18 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −17 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −16 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −15 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −14 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −13 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −12 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −11 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −10 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −9 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −8 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −7 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −6 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −5 | 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 | — |
| −4 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −3 | K131690 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −2 | K141010 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| −1 | K143472 | TE7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| 0 (this device) | K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co., Ltd. | 2018 | — |
| +1 | K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co., Ltd. | 2018 | — |
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 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 13 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143472 | TE7 Diagnostic Ultrasound SystemSummary page 24…e devices: Predicate Device Manufacturer Model 510(k) Control Number Predicate Mindray TE7 K143472 Reference device 1 EZONO AG EZONO 4000 K140254 Reference device 2 Mindray M7/M7T… | 2015 |
| † | K131690 | M7/M7T Diagnostic Ultrasound System | 2013 |
| † | K140254 | EZONO 4000 | 2014 |
| † | K161999 | Aixplorer | 2016 |
| † | K100830 | M7/M7T Diagnostic Ultrasound System | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | 2018 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 50 of the 200 ancestors have a recall of any class.
- Of its descendants, K182715 (Shenzhen Wisonic Medical Technology Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143472.
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 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes,thyroid,etc.),neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180461: Navi e/Navi s/Navi X Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180461
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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