510(k) · Cleared
ClearedDC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S
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 Jun 12, 2015 as substantially equivalent to K132341 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2013) and 2 other predicates after a 148-day review. Its family tree reaches back 22 generations to 1995. 79 later devices descend from it.
- Decided
- Jun 12, 2015
- Review
- 148 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K935595 (1995). 210 ancestors in all, the oldest K852159 (1985). 79 later devices descend from it, 7 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 2 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 1 generation backK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- This deviceK150080 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · cites it directly · 65 of its ownK152763 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · cites it directly · 53 of its ownK162267 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- Descendant · cites it directly · 35 of its ownK152543 M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 21 of its ownK171233 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017
- Descendant · cites it directly · 20 of its ownK170277 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
Show all 22 generations
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 20 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 19 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 18 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 16 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 15 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 14 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 13 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 12 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 11 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 10 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 9 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 8 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 7 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 6 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 5 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 4 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
- 3 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 2 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 1 generation backK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- This deviceK150080 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
2015high 11 (2025) · low 3 (2015)2026
Most influential descendants
Showing 5 of 79 · See all- K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly65descendants
- K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly53descendants
- K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly35descendants
- K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · 2 generations on21descendants
- K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −21 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −20 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −19 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −18 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −16 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −15 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −14 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −13 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −12 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −11 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −10 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −9 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −8 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −7 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −6 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −5 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −4 | 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 | — |
| −3 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −2 | K131690 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −1 | K141010 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| 0 (this device) | K150080 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +1 | K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +1 | K162267 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| +1 | K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017 | — |
| +1 | K170277 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | — |
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 | 15 | 0 |
| 2006 | 13 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 9 | 0 |
| 2020 | 5 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K132341 | DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsSummary page 4…diac Peripheral Peripheral vessel P| P P P P P P Note 1, 2, 4,6,7 vessel Other (Specify***) P| P P P P P Note 1, 2, 4,6,7 N=new indication; P=previously cleared by FDA-(K132341); E=added under Appendix E Additional comments: Combined modes--B+M. PW+B. Color + B. Power + B. PW +Color+ B. Power + PW +B.… | 2013 |
| * | K141010 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Summary page 30…n predicate K132341 device) 2 Mindray M9 K141010 3 GE Voluson E8 K132913 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diag… | 2014 |
| * | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10Summary page 30…ce) 2 Mindray M9 K141010 3 GE Voluson E8 K132913 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System employs the same technology as the predicate devices. All syst… | 2013 |
What descends from it? (79)
See all 797 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | 2015 | 65 |
| K162267 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | 2016 | 53 |
| K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | 2015 | 35 |
| K170277 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | 2017 | 20 |
| K152545 | DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems | 2015 | 13 |
| K163690 | DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | 2017 | 9 |
| K162055 | Acclarix LX8 Diagnostic Ultrasound System | 2017 | 8 |
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 20 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 54 of the 210 ancestors have a recall of any class.
- Of its descendants, K152763 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2015) has gone furthest, with 65 descendants of its own.
- 3 other devices also cite its predicate K132341.
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. 2015, 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-8/DC-8 PRO/DC-8 CV/DC-8S/DC-8 EXP 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, trans-rectal, transvaginal. musculo-skeletal (conventional, superficial), cardiac
adult, cardiac pediatric, peripheral vessel, urology and transesophageal (cardiac) exams.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150080
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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