510(k) · Cleared
ClearedSonoace X8 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison Co., Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Dec 10, 2009 as substantially equivalent to K063580 (Medison Co., Ltd., 2006) and 1 other predicate after an 8-day review. Its family tree reaches back 11 generations to 1993. 111 later devices descend from it.
- Decided
- Dec 10, 2009
- Review
- 8 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K924432 (1993). 19 ancestors in all. 111 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 7 generations between
- 3 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 2 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 1 generation backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- This deviceK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- Descendant · cites it directly · 110 of its ownK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · cites it directly · 108 of its ownK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · 2 generations on · 103 of its ownK103722 The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- Descendant · cites it directly · 102 of its ownK113381 Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · 2 generations on · 101 of its ownK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
Show all 11 generations
- Root · 11 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 10 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 9 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 8 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 7 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 6 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 5 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 4 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 3 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 2 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 1 generation backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- This deviceK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · cites it directly110descendants
- K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · cites it directly108descendants
- K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011 · 2 generations on103descendants
- K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · cites it directly102descendants
- K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · 2 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −10 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −9 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −8 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −7 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −6 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −5 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −4 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −3 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −2 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −1 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| 0 (this device) | K093714 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| +1 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +1 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +2 | K103722 | The Sonoace R5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| +1 | K113381 | Mysono U6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +2 | K132228 | Ugeo PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K063580 | Sonoace X8 Diagnostic Ultrasound SystemSummary page 1…IYO Diagnostic Ultrasound Transducer 892.1570 ITX 3. Identification of the predicate or legally marketed device: K063580, SONOACE X8 Diagnostic Ultrasound System K092159, ACCUVIX V20 Diagnostic Ultrasound System 4. Device Description:… | 2006 |
| * | K092159 | Accuvix V20 Diagnostic Ultrasound SystemSummary page 1…892.1570 ITX 3. Identification of the predicate or legally marketed device: K063580, SONOACE X8 Diagnostic Ultrasound System K092159, ACCUVIX V20 Diagnostic Ultrasound System 4. Device Description: The SONOACE X8 is a general purpose, mobile, soft… | 2009 |
What descends from it? (111)
See all 1113 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 16 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K102065 (Medison Co., Ltd., 2010) has gone furthest, with 110 descendants of its own.
- 4 other devices also cite its predicate K063580.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
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/K093714 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093714: Sonoace X8 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/K093714
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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