510(k) · Cleared
ClearedSsi-600/Ssi-800 Diagnostic Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoscape Company Limited · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 10, 2004 as substantially equivalent to K000030 (Medison America, Inc., 2000) after a 9-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jun 10, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000030 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000030 Sonoace 600 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- This deviceK041455 Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging SystemSonoscape Company Limited · 2004
- Descendant · cites it directly · 1 of its ownK101337 A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2010
- Descendant · 2 generations on · 0 of its ownK123616 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited · 2012
Most influential descendants
Showing 2 of 2 · See allView 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) | K041455 | Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging System | Sonoscape Company Limited | 2004 | — |
| +1 | K101337 | A6 Portable Ultrasonic Diagnostic System | Sonoscape Company Limited | 2010 | — |
| +2 | K123616 | Portable Ultrasonic Diagnostic System | Sonoscape Company Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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…lephone: (86) 755-26722890 Fax: (86) 755-26722850 Predicate: Medison SonoAce 600 K000030 Device Description: Model SSI-600/SSI-800 are linear and convex electronic… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101337 | A6 Portable Ultrasonic Diagnostic System | 2010 | 1 |
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/K041455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041455: Ssi-600/Ssi-800 Diagnostic 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/K041455
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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