510(k) · Cleared
ClearedEcho View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Medical Systems · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 12, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 12, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK003514 Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200Shimadzu Medical Systems · 2001
- Descendant · cites it directly · 1 of its ownK061643 Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PROShimadzu Medical Systems · 2006
- Descendant · cites it directly · 1 of its ownK061637 Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200PROShimadzu Medical Systems · 2006
- Descendant · 2 generations on · 0 of its ownK071287 Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200PROShimadzu Medical Systems · 2008
- Descendant · 2 generations on · 0 of its ownK071289 Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PROShimadzu Medical Systems · 2008
Most influential descendants
Showing 4 of 4 · See all- K061643Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PROShimadzu Medical Systems · 2006 · cites it directly1descendant
- K061637Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200PROShimadzu Medical Systems · 2006 · cites it directly1descendant
- K071287Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200PROShimadzu Medical Systems · 2008 · 2 generations on0descendants
- K071289Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PROShimadzu Medical Systems · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003514 | Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200 | Shimadzu Medical Systems | 2001 | — |
| +1 | K061643 | Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO | Shimadzu Medical Systems | 2006 | — |
| +1 | K061637 | Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200PRO | Shimadzu Medical Systems | 2006 | — |
| +2 | K071287 | Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200PRO | Shimadzu Medical Systems | 2008 | — |
| +2 | K071289 | Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO | Shimadzu Medical Systems | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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?
- Of its descendants, K061643 (Shimadzu Medical Systems, 2006) has gone furthest, with 1 descendant 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) | — |
https://510kreport.com/device/K003514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003514: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003514
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026