510(k) · Cleared
ClearedSonoace 9900 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 12, 2001 as substantially equivalent to K974269 (Medison America, Inc., 1998) after a 16-day review. Its family tree reaches back 2 generations to 1997. 132 later devices descend from it.
- Decided
- Sep 12, 2001
- Review
- 16 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961459 (1997). 132 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
- 1 generation backK974269 SA8800 Diagnostic Ultrasound System and Transducers,Medison America, Inc. · 1998
- This deviceK012867 Sonoace 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- Descendant · cites it directly · 131 of its ownK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- Descendant · 2 generations on · 129 of its ownK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- Descendant · 2 generations on · 125 of its ownK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- Descendant · 3 generations on · 124 of its ownK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- Descendant · 2 generations on · 123 of its ownK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 132 · See all- K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005 · cites it directly131descendants
- K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006 · 2 generations on129descendants
- K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007 · 2 generations on125descendants
- K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008 · 3 generations on124descendants
- K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009 · 2 generations on123descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961459 | Level 10 Hdi | Advanced Technology Laboratories, Inc. | 1997 | — |
| −1 | K974269 | SA8800 Diagnostic Ultrasound System and Transducers, | Medison America, Inc. | 1998 | — |
| 0 (this device) | K012867 | Sonoace 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| +1 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| +2 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| +2 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| +3 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| +2 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 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 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? (1)
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 |
|---|---|---|---|
| * | K974269 | SA8800 Diagnostic Ultrasound System and Transducers,Summary page 1…e predicate or legally marketed device: Medison believes that the SA9900 Ultrasound system are substantially equivalent to the currently marketed SA8800/HDI1500 System (K974269). 510(k) Summary of Safety and Effectiveness ATTACHMENT 1(b) 510(k) Premarket Notification _ SA9900 Ultrasound S… | 1998 |
| † | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | 2000 |
What descends from it? (132)
See all 1321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052911 | Accuvix XQ Diagnostic Ultrasound System | 2005 | 131 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K052911 (Medison Co., Ltd., 2005) has gone furthest, with 131 descendants of its own.
- 7 other devices also cite its predicate K974269.
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:
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012867: Sonoace 9900 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/K012867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026