510(k) · Cleared
ClearedMysono U6 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Medison Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 29, 2011 as substantially equivalent to K112646 (Samsung Medison Co., Ltd., 2011) and 3 other predicates after a 43-day review. Its family tree reaches back 14 generations to 1993. 102 later devices descend from it.
- Decided
- Dec 29, 2011
- Review
- 43 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K924432 (1993). 29 ancestors in all. 102 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 10 generations between
- 3 generations backK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 2 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 1 generation backK103722 The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- This deviceK113381 Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · cites it directly · 101 of its ownK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 2 generations on · 99 of its ownK142466 UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 3 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · cites it directly · 98 of its ownK133505 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 2 generations on · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Show all 14 generations
- Root · 14 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 13 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 12 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 11 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 10 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 9 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 8 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 7 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 6 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 5 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 4 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 3 generations backK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 2 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 1 generation backK103722 The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- This deviceK113381 Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · cites it directly101descendants
- K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 3 generations on98descendants
- K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · cites it directly98descendants
- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −13 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −12 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −11 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −10 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −9 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −8 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −7 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −6 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −5 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −4 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −3 | K093714 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −2 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −1 | K103722 | The Sonoace R5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| 0 (this device) | K113381 | Mysono U6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +1 | K132228 | Ugeo PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +2 | K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +3 | K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +1 | K133505 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +2 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K112646 | Sonoace R7 Diagnostic Ultrasound SystemSummary page 2…The MySono U6 is substantially equivalent with respect to safety, effectiveness, and functionality to the SONOACE R7 Diagnostic Ultrasound System (K 112646), SONOACE X8 Diagnostic Ultrasound System (K093714) , MySono U5 Diagnostic Ultrasound System (K100 186), and SONOACE R… | 2011 |
| * | K093714 | Sonoace X8 Diagnostic Ultrasound SystemSummary page 1…f the predicate or legally marketed device: - SONOACE R7 Diag-nostic Ultrasound System (KI 12646) - SONOACE XS Diagnostic Ultrasound System (K093714) - MkySono US Diagntostic Ultrasound System (KIOO 186) - SONOACE R5 Diagnostic Ultrasound System (K10… | 2009 |
| * | K100186 | Mysono U5 Diagnostic Ultrasound SystemSummary page 2…the SONOACE R7 Diagnostic Ultrasound System (K 112646), SONOACE X8 Diagnostic Ultrasound System (K093714) , MySono U5 Diagnostic Ultrasound System (K100 186), and SONOACE R5 Diagnostic Ultrasound System (K103722). All systems transmrit ultrasonic energy into patie… | 2010 |
| * | K103722 | The Sonoace R5 Diagnostic Ultrasound SystemSummary page 1…CE XS Diagnostic Ultrasound System (K093714) - MkySono US Diagntostic Ultrasound System (KIOO 186) - SONOACE R5 Diagnostic Ultrasound System (K103722) 510(k) Siniiiiarv / Statemient Certificanion ATTACFIENENT I === Page 2… | 2011 |
What descends from it? (102)
See all 1022 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 18 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K132228 (Samsung Medison Co., Ltd., 2013) has gone furthest, with 101 descendants of its own.
- 4 other devices also cite its predicate K112646.
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. 2011, 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 MySono U6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113381: Mysono U6 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/K113381
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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