510(k) · Cleared
ClearedDC-N3/DC-N3S Diagnostic Ultrasound System
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 Feb 19, 2014 as substantially equivalent to K123503 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2012) and 3 other predicates after a 44-day review. Its family tree reaches back 21 generations to 1995. 5 later devices descend from it.
- Decided
- Feb 19, 2014
- Review
- 44 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K935595 (1995). 187 ancestors in all, the oldest K852159 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations between
- 3 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
- 2 generations backK120699 DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 1 generation backK123503 DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- This deviceK140030 DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK173369 DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK162845 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK223917 Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno…Vinno Technology (Suzhou) Co.,Ltd · 2023
- Descendant · 2 generations on · 0 of its ownK201990 DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK183377 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
Show all 21 generations
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 19 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 18 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 17 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 16 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 15 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 14 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 13 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 12 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 11 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 10 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 9 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 8 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 7 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 6 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 5 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 4 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 3 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
- 2 generations backK120699 DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 1 generation backK123503 DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- This deviceK140030 DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
Most influential descendants
Showing 5 of 5 · See all- K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · cites it directly2descendants
- K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly1descendant
- K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd · 2023 · 2 generations on0descendants
- K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · 2 generations on0descendants
- K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −20 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −19 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −18 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −17 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −16 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −15 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −14 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −13 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −12 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −11 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −10 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −9 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −8 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −7 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −6 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −5 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −4 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −3 | 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 | — |
| −2 | K120699 | DC-T6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −1 | K123503 | DC-N3/DC-NS3 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| 0 (this device) | K140030 | DC-N3/DC-N3S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| +1 | K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017 | — |
| +1 | K162845 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| +2 | K223917 | Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P… | Vinno Technology (Suzhou) Co.,Ltd | 2023 | — |
| +2 | K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | — |
| +2 | K183377 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
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 | 12 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 12 | 0 |
| 2007 | 10 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K123503 | DC-N3/DC-NS3 Diagnostic Ultrasound SystemSummary page 2…exams. 5. Summary of Modifications and Newly Added Features This submission device is a modification to DC-N3/DC-N3S Diagnostic Ultrasound System previously cleared in K 123503. The following is a brief overview of the modifications and newly added features. Detailed information is found in 006_-Device De… | 2012 |
| * | K103583 | DC-7 Diagnostic Ultrasound SystemSummary page 3…predicate K 123503 ____________ _____________ device) ________ 2 Mindray DC-7 K 103583 3 Mindray DC-T6 K 120699 4 GE Voluson E8… | 2010 |
| * | K120699 | DC-T6 Diagnostic Ultrasound SystemSummary page 3…________ 2 Mindray DC-7 K 103583 3 Mindray DC-T6 K 120699 4 GE Voluson E8 K101236 DC-N3/DC-N35 Diagnostic Ultrasound System employs th… | 2012 |
| * | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BMSummary page 3…K 103583 3 Mindray DC-T6 K 120699 4 GE Voluson E8 K101236 DC-N3/DC-N35 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic e… | 2011 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 43 of the 187 ancestors have a recall of any class.
- Of its descendants, K173369 (Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K123503.
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. 2014, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2007high 64 (2017) · low 13 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
2007high 124 (2025) · low 18 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
2007high 16 (2007) · low 0 (2017)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
2007high 610 (2025) · low 2 (2008)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 DC-N3,DC-N3S Diagnostic Ultrasound System is applicable for adult, pregnant woman, pediatric and neonate. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes.), cephalic (neonatal and adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140030: DC-N3/DC-N3S 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/K140030
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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