510(k) · Cleared
ClearedSonoace X6 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 2, 2008 as substantially equivalent to K043455 (Medison Co., Ltd., 2004) and 1 other predicate after a 15-day review. Its family tree reaches back 8 generations to 1993. 105 later devices descend from it.
- Decided
- Jul 2, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K924432 (1993). 18 ancestors in all. 105 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 7 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 6 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 5 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 4 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 3 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 2 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 1 generation backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- This deviceK081676 Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- Descendant · cites it directly · 104 of its ownK101829 The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 2 generations on · 103 of its ownK103722 The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- Descendant · 3 generations on · 102 of its ownK113381 Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · 4 generations on · 101 of its ownK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 5 generations on · 99 of its ownK142466 UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · cites it directly104descendants
- K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011 · 2 generations on103descendants
- K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · 3 generations on102descendants
- K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · 4 generations on101descendants
- K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 5 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −7 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −6 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −5 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −4 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −3 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −2 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −1 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| 0 (this device) | K081676 | Sonoace X6 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| +1 | K101829 | The Sonoace R3 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +2 | K103722 | The Sonoace R5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| +3 | K113381 | Mysono U6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +4 | K132228 | Ugeo PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +5 | K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K043455 | SA8000 SE Diagnostic Ultrasound SystemSummary page 1…90-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX 3. Identification of the predicate or legally marketed device: K043455, 12/21/2004, SA8000 SE Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System 4.… | 2004 |
| * | K063580 | Sonoace X8 Diagnostic Ultrasound SystemSummary page 1…2.1570 90-ITX 3. Identification of the predicate or legally marketed device: K043455, 12/21/2004, SA8000 SE Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System 4. Device Description: The SONOACE X6 is a general purpose, mob… | 2006 |
What descends from it? (105)
See all 1051 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101829 | The Sonoace R3 Diagnostic Ultrasound System | 2010 | 104 |
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 15 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K101829 (Medison Co., Ltd., 2010) has gone furthest, with 104 descendants of its own.
- 4 other devices also cite its predicate K043455.
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. 2008, 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?
Diagnostic ultrasound imaing or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaing or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow…
Read the full statement (130 words)
Diagnostic ultrasound imaing or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaing or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081676: Sonoace X6 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/K081676
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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