510(k) · Cleared
ClearedSiui CTS-900 Digital Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instuments · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 16, 2008 as substantially equivalent to K061083 (Shantou Institute of Ultrasonic Instuments, 2006) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- May 16, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000030 (2000). 7 ancestors in all, the oldest K924432 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK000030 Sonoace 600 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 2 generations backK012772 CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2001
- 1 generation backK061083 CTS-7700Shantou Institute of Ultrasonic Instuments · 2006
- This deviceK081110 Siui CTS-900 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000030 | Sonoace 600 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −2 | K012772 | CTS-485 Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2001 | — |
| −1 | K061083 | CTS-7700 | Shantou Institute of Ultrasonic Instuments | 2006 | — |
| 0 (this device) | K081110 | Siui CTS-900 Digital Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061083 | CTS-7700Summary page 1…Dublin, CA 94568 Telephone: 1-925-556-1302 Fax: 1-866-718-3819 Predicate Device: SIUI CTS-7700, K061083 and K070982 Device Description: The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating m… | 2006 |
| * | K070982 | CTS-7700 Digital Ultrasound Imaging SystemSummary page 1…A 94568 Telephone: 1-925-556-1302 Fax: 1-866-718-3819 Predicate Device: SIUI CTS-7700, K061083 and K070982 Device Description: The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081110: Siui CTS-900 Digital Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081110
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