510(k) · Cleared
ClearedSA8000 SE 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 Dec 21, 2004 as substantially equivalent to K013627 (Medison America, Inc., 2001) and 1 other predicate after a 6-day review. Its family tree reaches back 6 generations to 1993. 182 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 6 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924432 (1993). 13 ancestors in all. 182 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 5 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 4 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 3 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 2 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 1 generation backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- This deviceK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- Descendant · cites it directly · 114 of its ownK061213 Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- Descendant · 2 generations on · 111 of its ownK100186 Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 3 generations on · 110 of its ownK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 4 generations on · 108 of its ownK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- Descendant · cites it directly · 105 of its ownK081676 Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 182 · See all- K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006 · cites it directly114descendants
- K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · 2 generations on111descendants
- K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · 3 generations on110descendants
- K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · 4 generations on108descendants
- K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008 · cites it directly105descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −5 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −4 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −3 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −2 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −1 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| 0 (this device) | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| +1 | K061213 | Sonoace Pico Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| +2 | K100186 | Mysono U5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +3 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +4 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| +1 | K081676 | Sonoace X6 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K013627 | Sonoace SA-8000 Diagnostic Ultrasound SystemSummary page 2…diac, trans-rectal, trans-vaginal, peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA8000 (K013627) and mycolor2o2 (K031552) The system can be used to measure distances and calculate areas, circumferences… | 2001 |
| * | K031552 | Mycolor 202 Diagnostic Ultrasound System and TransducersSummary page 1…000 SE ultrasound system is substantially equivalent to the currently marketed SA 8000 ultrasound system (KG 13627) and mycolor202 ultrasound system (K03 1552) 4) Device Description: The SA8000 SE system is a general purpose, mobile, software controlled, diagnost… | 2003 |
What descends from it? (182)
See all 1825 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061213 | Sonoace Pico Diagnostic Ultrasound System | 2006 | 114 |
| K081676 | Sonoace X6 Diagnostic Ultrasound System | 2008 | 105 |
| K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | 2006 | 62 |
| K053154 | MYLAB15/20 3D/4D Ultrasound Imaging System | 2005 | 29 |
| K053530 | Sonoace X4 Diagnostic Ultrasound System | 2006 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K061213 (Medison Co., Ltd., 2006) has gone furthest, with 114 descendants of its own.
- 5 other devices also cite its predicate K013627.
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.
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 imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043455: SA8000 SE 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/K043455
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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