510(k) · Cleared
ClearedAccuvix XQ 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 Oct 31, 2005 as substantially equivalent to K032329 (Medison America, Inc., 2003) and 2 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1993. 131 later devices descend from it.
- Decided
- Oct 31, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K924432 (1993). 14 ancestors in all. 131 later devices descend from it, 4 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 backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- This deviceK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- Descendant · cites it directly · 129 of its ownK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- Descendant · cites it directly · 125 of its ownK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- Descendant · 2 generations on · 124 of its ownK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- Descendant · cites it directly · 123 of its ownK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- Descendant · 2 generations on · 112 of its ownK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
Showing 5 of 131 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 131 · See all- K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006 · cites it directly129descendants
- K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007 · cites it directly125descendants
- K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008 · 2 generations on124descendants
- K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009 · cites it directly123descendants
- K093849Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · 2 generations on112descendants
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 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| 0 (this device) | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| +1 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| +1 | 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 | — |
| +2 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K032329 | SA 9900 Plus Diagnostic Ultrasound SystemSummary page 1…ison Co., Ltd. believes that ACCUVIX XQ TN4 ultrasound system is substantially equivalent to the currently marketed SONOACE 9900 PLJUS ultrasound system (K032329) and SONOACE 9900 Uhtirasound system (K0 12867 and K002185) 4. Device Description: The ACCIJVIX XQ "'i is… | 2003 |
| * | K012867 | Sonoace 9900 Diagnostic Ultrasound SystemSummary page 1…trasound system is substantially equivalent to the currently marketed SONOACE 9900 PLJUS ultrasound system (K032329) and SONOACE 9900 Uhtirasound system (K0 12867 and K002185) 4. Device Description: The ACCIJVIX XQ "'i is a general purpose, mobile, software controlled… | 2001 |
| * | K002185 | Sonoace SA 9900 Diagnostic Ultrasound SystemSummary page 1…substantially equivalent to the currently marketed SONOACE 9900 PLJUS ultrasound system (K032329) and SONOACE 9900 Uhtirasound system (K0 12867 and K002185) 4. Device Description: The ACCIJVIX XQ "'i is a general purpose, mobile, software controlled, diagnostic… | 2000 |
What descends from it? (131)
See all 1314 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 12 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K063580 (Medison Co., Ltd., 2006) has gone furthest, with 129 descendants of its own.
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 fow 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/K052911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052911: Accuvix XQ 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/K052911
Report an extraction error
Are you the manufacturer?
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