510(k) · Cleared
ClearedEchoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100
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 Apr 1, 2005 as substantially equivalent to K991611 (General Electric Co., 1999) after a 31-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 1, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933202 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 2 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- 1 generation backK991611 GE Logiq 500General Electric Co. · 1999
- This deviceK050510 Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100Shimadzu Medical Systems · 2005
- Descendant · cites it directly · 1 of its ownK061641 Echo View/Shimasonic Diagnostic Ultrasound System, Model SaranoShimadzu Medical Systems · 2006
- Descendant · 2 generations on · 0 of its ownK082224 Diagnostic Ultrasound System Sarano, Echo View, ShimasonicShimadzu Medical Systems · 2008
- Descendant · cites it directly · 0 of its ownK071291 Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1100Shimadzu Medical Systems · 2008
Most influential descendants
Showing 3 of 3 · See all- K061641Echo View/Shimasonic Diagnostic Ultrasound System, Model SaranoShimadzu Medical Systems · 2006 · cites it directly1descendant
- K082224Diagnostic Ultrasound System Sarano, Echo View, ShimasonicShimadzu Medical Systems · 2008 · 2 generations on0descendants
- K071291Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1100Shimadzu Medical Systems · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −2 | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| −1 | K991611 | GE Logiq 500 | General Electric Co. | 1999 | — |
| 0 (this device) | K050510 | Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100 | Shimadzu Medical Systems | 2005 | — |
| +1 | K061641 | Echo View/Shimasonic Diagnostic Ultrasound System, Model Sarano | Shimadzu Medical Systems | 2006 | — |
| +2 | K082224 | Diagnostic Ultrasound System Sarano, Echo View, Shimasonic | Shimadzu Medical Systems | 2008 | — |
| +1 | K071291 | Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1100 | Shimadzu Medical Systems | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K991611 | GE Logiq 500Summary page 1…Diagnostic Ultrasound Transducer FR # 892.1570, Product Code 90-ITX. 2.4 Predicate Device: GE Logiq 500 (K99161 1,6/9/99) 3.0 DEVICE DESCRIPTION The SDU-1 100 is a mobile diagnostic ultrasound system. This system has flat linear arra… | 1999 |
What descends from it? (3)
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K061641 (Shimadzu Medical Systems, 2006) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K991611.
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 Doppler 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/K050510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050510
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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