510(k) · Cleared
ClearedThe Sonoace R3 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 Jul 16, 2010 as substantially equivalent to K081676 (Medison Co., Ltd., 2008) and 1 other predicate after a 15-day review. Its family tree reaches back 9 generations to 1993. 104 later devices descend from it.
- Decided
- Jul 16, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K924432 (1993). 20 ancestors in all. 104 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 5 generations between
- 3 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 2 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 1 generation backK081676 Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- This deviceK101829 The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · cites it directly · 103 of its ownK103722 The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- Descendant · 2 generations on · 102 of its ownK113381 Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · 3 generations on · 101 of its ownK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 4 generations on · 99 of its ownK142466 UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 5 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
Show all 9 generations
- Root · 9 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 8 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 7 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 6 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 5 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 4 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 3 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 2 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 1 generation backK081676 Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- This deviceK101829 The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011 · cites it directly103descendants
- K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · 2 generations on102descendants
- K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · 3 generations on101descendants
- K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 4 generations on99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 5 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −8 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −7 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −6 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −5 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −4 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −3 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −2 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −1 | K081676 | Sonoace X6 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| 0 (this device) | K101829 | The Sonoace R3 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +1 | K103722 | The Sonoace R5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| +2 | K113381 | Mysono U6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +3 | K132228 | Ugeo PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +4 | K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +5 | K143264 | H60 V2.00 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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K081676 | Sonoace X6 Diagnostic Ultrasound SystemSummary page 1…LYO Diagnostic Ultrasound Transducer 892.1570 [TX 3. Identification of the predicate or legally marketed device: K08 1676, SONOACE X6 Diagnostic Ultrasound System K061213, SONOACE PICO Diagnostic Ultrasound System 510(k) Summary / Statem… | 2008 |
| * | K061213 | Sonoace Pico Diagnostic Ultrasound SystemSummary page 1…892.1570 [TX 3. Identification of the predicate or legally marketed device: K08 1676, SONOACE X6 Diagnostic Ultrasound System K061213, SONOACE PICO Diagnostic Ultrasound System 510(k) Summary / Statement Certification… | 2006 |
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103722 | The Sonoace R5 Diagnostic Ultrasound System | 2011 | 103 |
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 17 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K103722 (Medison Co., Ltd., 2011) has gone furthest, with 103 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The SONOACE R3 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 Organs, Neonatal Cephalic, Trans-rectal, trans-vaginal, Muscular-Skeletal (conventional, superficial), Cardiac Adult and Peripheral-vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101829 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101829: The Sonoace R3 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101829
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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