510(k) · Cleared
ClearedResona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 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 11, 2026 as substantially equivalent to K242231 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2024) after a 142-day review. Its family tree reaches back 29 generations to 1995.
- Decided
- Feb 11, 2026
- Review
- 142 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 29 generations to K935595 (1995). 241 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet.
- Root · 29 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 25 generations between
- 3 generations backK202785 Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2021
- 2 generations backK222928 Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2023
- 1 generation backK242231 Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024
- This deviceK253049 Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
Show all 29 generations
- Root · 29 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 28 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 27 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 26 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 25 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 24 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 23 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 22 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 21 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 20 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 19 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 18 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 17 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 16 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 15 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 14 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 13 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 12 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 11 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
- 10 generations backK120699 DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 9 generations backK123503 DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 8 generations backK132779 DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 7 generations backK150204 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 6 generations backK152763 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 5 generations backK162267 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
- 4 generations backK171233 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017
- 3 generations backK202785 Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2021
- 2 generations backK222928 Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2023
- 1 generation backK242231 Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024
- This deviceK253049 Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −28 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −27 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −26 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −25 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −24 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −23 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −22 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −21 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −20 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −19 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −18 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −17 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −16 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −15 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −14 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −13 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −12 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −11 | 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 | — |
| −10 | K120699 | DC-T6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −9 | K123503 | DC-N3/DC-NS3 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −8 | K132779 | DC-N2/DC-N2S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −7 | K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −6 | K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −5 | K162267 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
| −4 | K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017 | — |
| −3 | K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2021 | — |
| −2 | K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023 | — |
| −1 | K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | — |
| 0 (this device) | K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | — |
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 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 17 | 0 |
| 2005 | 16 | 0 |
| 2006 | 13 | 0 |
| 2007 | 10 | 0 |
| 2008 | 10 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Summary page 6…h and Page 1 of 6 substantially equivalent to the predicate devices listed below. Resona A10S (K242231) is the main predicate device. Device 510K Dev… | 2024 |
| † | K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)… | 2025 |
| † | K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic… | 2023 |
| † | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50… | 2016 |
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 31 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 61 of the 241 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. 2026, 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?
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. Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV…
Read the full statement (190 words)
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.
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for Pediatric application in Cardiac, Liver and Urinary Tract).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253049: Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253049
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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