510(k) · Cleared
ClearedSonoview Pro by Medison CO., LTD.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jun 30, 2003 as substantially equivalent to K022692 (Mevisys Co., Ltd., 2002) after a 12-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.
- Decided
- Jun 30, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954678 (1996). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- This deviceK031886 Sonoview Pro by Medison CO., LTD.Medison Co., Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK151808 3D/5D ViewerSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK161955 5D ViewerSamsung Medison Co., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK172513 3D EchoJointvue, LLC · 2017
- Descendant · 4 generations on · 0 of its ownK211656 3D Echo v1.1Jointvue, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK180883 5D ViewerSamsung Medison Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K1518083D/5D ViewerSamsung Medison Co., Ltd. · 2015 · cites it directly4descendants
- K1619555D ViewerSamsung Medison Co., Ltd. · 2016 · 2 generations on3descendants
- K1725133D EchoJointvue, LLC · 2017 · 3 generations on1descendant
- K2116563D Echo v1.1Jointvue, LLC · 2021 · 4 generations on0descendants
- K1808835D ViewerSamsung Medison Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| 0 (this device) | K031886 | Sonoview Pro by Medison CO., LTD. | Medison Co., Ltd. | 2003 | — |
| +1 | K151808 | 3D/5D Viewer | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K161955 | 5D Viewer | Samsung Medison Co., Ltd. | 2016 | — |
| +3 | K172513 | 3D Echo | Jointvue, LLC | 2017 | — |
| +4 | K211656 | 3D Echo v1.1 | Jointvue, LLC | 2021 | — |
| +3 | K180883 | 5D Viewer | Samsung Medison Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K022692 | Voxelplus Pacs | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151808 | 3D/5D Viewer | 2015 | 4 |
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 7 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151808 (Samsung Medison Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K022692.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
SonoView ProTM by Medison Co. Ltd. is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. Ultrasound, CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031886: Sonoview Pro by Medison CO., LTD..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031886
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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