510(k) · Cleared
ClearedCTS-485 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 Oct 1, 2001 as substantially equivalent to K000030 (Medison America, Inc., 2000) after a 45-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Oct 1, 2001
- Review
- 45 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000030 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000030 Sonoace 600 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- This deviceK012772 CTS-485 Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2001
- Descendant · cites it directly · 1 of its ownK061083 CTS-7700Shantou Institute of Ultrasonic Instuments · 2006
- Descendant · 2 generations on · 0 of its ownK081110 Siui CTS-900 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2008
- Descendant · cites it directly · 0 of its ownK061488 CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging SystemShantou Institute of Ultrasonic Instruments (Siui · 2006
Most influential descendants
Showing 3 of 3 · See all- K061083CTS-7700Shantou Institute of Ultrasonic Instuments · 2006 · cites it directly1descendant
- K081110Siui CTS-900 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2008 · 2 generations on0descendants
- K061488CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging SystemShantou Institute of Ultrasonic Instruments (Siui · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000030 | Sonoace 600 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| 0 (this device) | K012772 | CTS-485 Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2001 | — |
| +1 | K061083 | CTS-7700 | Shantou Institute of Ultrasonic Instuments | 2006 | — |
| +2 | K081110 | Siui CTS-900 Digital Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2008 | — |
| +1 | K061488 | CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging System | Shantou Institute of Ultrasonic Instruments (Siui | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K000030 | Sonoace 600 Diagnostic Ultrasound SystemSummary page 1…ou Sez, 515041, China Corrresponding Official: Mr. Jinzhong Yao Title: President Telephone: (86) 754-8250150 Fax: (86) 754-8251499 Predicate: MEDISON Co. SONOACE 600, K000030 Device Description: Model CTS-485 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan conver… | 2000 |
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?
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.
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 fetal imaging and other abdominal as well as pediatric, small organ cardiac.
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/K012772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012772: CTS-485 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/K012772
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026