510(k) · Cleared
ClearedVinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55, Vinno E35, Vinno X65, Vinno X55, Vinno X35, Vinno G55E, Vinno G55P, Vinno M55E, Vinno M55P, Vinno E35E, Vinno E35P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vinno Technology (Suzhou) Co.,Ltd · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 17, 2023 as substantially equivalent to K180409 (Samsung Medison Co., Ltd., 2018) after a 170-day review. Its family tree reaches back 29 generations to 1993.
- Decided
- Jun 17, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 29 generations to K924432 (1993). 279 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 29 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 25 generations between
- 3 generations backK170493 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 2 generations backK172129 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 1 generation backK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- This deviceK223920 Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6…Vinno Technology (Suzhou) Co.,Ltd · 2023
Show all 29 generations
- Root · 29 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 28 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 27 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 26 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 25 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 24 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 23 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 22 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 21 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 20 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 19 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 18 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 17 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 16 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 15 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 14 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 13 generations backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 12 generations backK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 11 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 10 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 9 generations backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 8 generations backK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 7 generations backK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 6 generations backK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- 5 generations backK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- 4 generations backK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 3 generations backK170493 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 2 generations backK172129 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 1 generation backK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- This deviceK223920 Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6…Vinno Technology (Suzhou) Co.,Ltd · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −28 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −27 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −26 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −25 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −24 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −23 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −22 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −21 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −20 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −19 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −18 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −17 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −16 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −15 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −14 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −13 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −12 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −11 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −10 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −9 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −8 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −7 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −6 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| −5 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| −4 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −3 | K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −2 | K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −1 | K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| 0 (this device) | K223920 | Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7… | Vinno Technology (Suzhou) Co.,Ltd | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 10 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 23 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 11 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 14 | 0 |
| 2013 | 13 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K180409 | HS40 Diagnostic Ultrasound SystemSummary page 4…tem Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: k180409 IV Device description The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VIN… | 2018 |
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 7 months on median.
- 68 of the 279 ancestors have a recall of any class.
- 3 other devices also cite its predicate K180409.
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. 2023, 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 device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid. This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small…
Read the full statement (120 words)
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications.
The operating modes supported by the device are B mode, Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, 4D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223920: Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55, Vinno E35, Vinno X65, Vinno X55, Vinno X35, Vinno G55E, Vinno G55P, Vinno M55E, Vinno M55P, Vinno E35E, Vinno E35P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223920
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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